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Trial record 13 of 59 for:    MLN8237

Study of MLN8237 in Participants With Advanced Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00697346
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions B-cell Follicular Lymphoma
B-cell Marginal Zone Lymphoma
Diffuse Large B-cell Lymphoma
B-cell Mantle Cell Lymphoma
B-cell Small Lymphocytic Lymphoma
B-Cell Chronic Lymphocytic Leukemia
Multiple Myeloma
Waldenstrom's Macroglobulinemia
Noncutaneous Peripheral T-cell Lymphoma Not Otherwise Specified
Angioimmunoblastic T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Enteropathy Associated T-cell Lymphoma
NK Lymphoma
Intervention Drug: Alisertib
Enrollment 58
Recruitment Details Participants took part in the study at 10 investigative sites in the United States from 11 July 2008 to19 October 2016.
Pre-assignment Details Participants with a diagnosis of advanced hematological malignancies were enrolled 1 of 3 treatment groups, Part 1:alisertib powder-in capsule (PIC) 25 to 90 mg dose escalation cohort, Part 1: alisertib 30 to 50 mg enteric-coated tablet (ECT) dose escalation cohort, or Part 2: alisertib ECT 50 mg participants with peripheral T-cell lymphoma (PTCL).
Arm/Group Title Part 1: PIC Dose Escalation Part 1: ECT Dose Escalation Part 2: PTCL
Hide Arm/Group Description Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment. Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles). Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
Period Title: Overall Study
Started 28 28 2
Completed 0 [1] 2 [2] 1 [3]
Not Completed 28 26 1
Reason Not Completed
Adverse Event             4             5             0
Progressive Disease             19             18             0
Symptomatic Deterioration             0             1             0
Withdrawal by Subject             2             2             0
Reason not Specified             3             0             1
[1]
Completed = participants who completed study treatment.
[2]
2 participants were ongoing as of primary completion date 27 Dec 2011 and have now completed.
[3]
1 participant was ongoing as of primary completion date 27 Dec 2011 and has now completed.
Arm/Group Title Part 1: PIC Dose Escalation Part 1: ECT Dose Escalation Part 2: PTCL Total
Hide Arm/Group Description Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment. Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles). Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). Total of all reporting groups
Overall Number of Baseline Participants 28 28 2 58
Hide Baseline Analysis Population Description
Safety population is defined as all participants who received any amount of alisertib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 2 participants 58 participants
61.4  (8.91) 59.5  (14.22) 63.0  (24.04) 60.5  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 2 participants 58 participants
Female
14
  50.0%
15
  53.6%
2
 100.0%
31
  53.4%
Male
14
  50.0%
13
  46.4%
0
   0.0%
27
  46.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 2 participants 58 participants
Hispanic or Latino
9
  32.1%
7
  25.0%
0
   0.0%
16
  27.6%
Not Hispanic or Latino
19
  67.9%
20
  71.4%
2
 100.0%
41
  70.7%
Unknown or Not Reported
0
   0.0%
1
   3.6%
0
   0.0%
1
   1.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 28 participants 28 participants 2 participants 58 participants
24 26 2 52
Black or African American Number Analyzed 28 participants 28 participants 2 participants 58 participants
3 1 0 4
Asian Number Analyzed 28 participants 28 participants 2 participants 58 participants
0 1 0 1
Not Reported Number Analyzed 28 participants 28 participants 2 participants 58 participants
1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 2 participants 58 participants
28 28 2 58
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 28 participants 26 participants 2 participants 56 participants
165.9  (11.25) 164.6  (10.95) 160.6  (6.43) 165.1  (10.89)
[1]
Measure Analysis Population Description: Here number analyzed is the number of participants who were evaluated for height at baseline.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 28 participants 28 participants 2 participants 58 participants
81.40  (20.031) 77.62  (19.747) 97.65  (43.911) 80.13  (20.573)
Body Surface Area   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 28 participants 26 participants 2 participants 56 participants
1.93  (0.282) 1.88  (0.289) 2.05  (0.434) 1.91  (0.286)
[1]
Measure Description: Body Surface Area =square root [height (cm) * weight (kg) / 3600].
[2]
Measure Analysis Population Description: Here number analyzed is the number of participants who were evaluated for body surface area at baseline.
1.Primary Outcome
Title Number of Participants With Dose-Limiting Toxicity (DLT)
Hide Description DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:1. Grade 4 neutropenia lasting ≥7 consecutive days, 2. Grade 4 neutropenia with fever and/or infection 3. Platelet count <25,000/mm^3 4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis 5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide 6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (<1 week) Grade 3 fatigue 7. Treatment delay of >21 days due to failure of adequate hematologic or non-hematologic recovery from previous cycle of treatment 8. Other alisertib related non-hematologic toxicities ≥Grade 2 that, in the opinion of the investigator required a dose reduction or discontinuation of therapy with alisertib.
Time Frame From first dose of study drug to 30 days after the last dose (up to 422 days)
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D Alisertib 90 mg PIC QD 14D Alisertib 40 mg ECT QD 14D Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 Ddays followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 4 3 6 6 2 4 3 7 9
Measure Type: Number
Unit of Measure: participants
1 2 0 1 2 2 2 0 0 1
2.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Alisertib
Hide Description MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 participants.
Time Frame From first dose of study drug to 30 days after the last dose (up to 422 days)
Hide Outcome Measure Data
Hide Analysis Population Description
DLT evaluable population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow up data to allow the investigators and sponsor to determine whether DLT occurred.
Arm/Group Title Alisertib
Hide Arm/Group Description:
Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: mg BID for 7 days
50
3.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
833.2
(49.5%)
1078.3
(26.4%)
4.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
1337.6
(57.8%)
1451.9
(26.2%)
5.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 4
Median (Full Range)
Unit of Measure: hours (h)
2.0
(2.0 to 3.3)
2.0
(1.1 to 5.2)
6.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 3
Median (Full Range)
Unit of Measure: h
2.0
(1.0 to 5.0)
2.0
(2.0 to 2.0)
7.Primary Outcome
Title AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM*h
14846
(69.7%)
16528
(35.6%)
8.Primary Outcome
Title Terminal Half-Life (t1/2) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 5 3
Mean (Standard Deviation)
Unit of Measure: h
20.5  (7.3) 19.5  (6.0)
9.Primary Outcome
Title Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple time points (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: ratio
1.9  (1.1) 1.5  (0.5)
10.Primary Outcome
Title Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: ratio
6.0  (4.4) 4.3  (1.5)
11.Primary Outcome
Title CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing at Day 21
Hide Description [Not Specified]
Time Frame Cycle 1 Day 21 predose and at multiple timepoints (up to 6 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis, with data available at the given time point. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 25mg PIC QD 21D Alisertib 35 mg PIC QD 21D
Hide Arm/Group Description:
Alisertib 25 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days (D) followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
3.2
(113%)
4.1
(45%)
12.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D Alisertib 90 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 6 7 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
726.5
(34.8%)
1637.0
(58.0%)
1773.4
(44.3%)
2497.4
(24.3%)
13.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
2193.5 [1] 
(NA%)
1634.4
(52.5%)
2300.2
(40.3%)
[1]
Geometric Coefficient of Variation was not calculated for 2 participants.
14.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D Alisertib 90 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 90 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 6 7 2
Median (Full Range)
Unit of Measure: h
2.0
(1.9 to 4.0)
3.0
(1.1 to 4.0)
2.0
(1.9 to 6.0)
2.9
(1.5 to 4.3)
15.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2 5 6
Median (Full Range)
Unit of Measure: h
3.4
(0.8 to 6.1)
2.0
(2.0 to 4.0)
2.0
(1.5 to 2.1)
16.Primary Outcome
Title AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM*h
23444 [1] 
(1.9% to 4.0%)
19671
(1.1% to 4.0%)
28864
(1.9% to 6.0%)
[1]
Geometric Coefficient of Variation was not calculated for 2 participants.
17.Primary Outcome
Title Accumulation Ratio (Rac) for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2 5 6
Mean (Standard Deviation)
Unit of Measure: ratio
2.4  (0.00) 1.5  (0.5) 1.9  (1.6)
18.Primary Outcome
Title Peak/Trough Ratio for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2 5 6
Mean (Standard Deviation)
Unit of Measure: ratio
4.1 [1]   (NA) 5.4  (1.9) 4.4  (0.8)
[1]
Standard deviation was not calculated for 2 participants.
19.Primary Outcome
Title CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Pill in Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 35 mg PIC QD 14D Alisertib 45 mg PIC QD 14D Alisertib 65 mg PIC QD 14D
Hide Arm/Group Description:
Alisertib 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 45 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity to (up 4 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 65 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
2.9 [1] 
(1.9% to 4.0%)
4.3
(1.1% to 4.0%)
4.3
(1.9% to 6.0%)
[1]
Geometric Coefficient of Variation was not calculated for 2 participants.
20.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
1227
(41.3%)
21.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
1608 [1] 
(NA%)
[1]
Geometric Coefficient of Variation was not calculated for 2 participants.
22.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 24 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: h
3.9
(2.0 to 6.1)
23.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: h
5.0
(4.0 to 6.0)
24.Primary Outcome
Title AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM*h
14306
(2.0% to 6.1%)
25.Primary Outcome
Title Terminal Half Life for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: h
11.7 [1]   (NA)
[1]
Standard deviation is not estimable for 1 participant.
26.Primary Outcome
Title Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: ratio
2.1 [1]   (NA)
[1]
Standard deviation is not estimable for 1 participant.
27.Primary Outcome
Title CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Once Daily for 14 Days (QD14D) Dosing at Day 14
Hide Description [Not Specified]
Time Frame Cycle 1 Day 14 predose and at multiple timepoints (up to 8 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Alisertib 40 mg ECT QD 14D
Hide Arm/Group Description:
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles until disease progression or unacceptable alisertib-related toxicity (up to 3 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: L/h
2.5 [1]   (NA)
[1]
Standard deviation is not estimable for 1 participant.
28.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
886
(39.7%)
1114
(37.1%)
1531
(58.4%)
29.Primary Outcome
Title Cmax: Maximum Observed Concentration for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM
2025
(29.6%)
2586
(35.7%)
2058
(44.6%)
30.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 9 10
Median (Full Range)
Unit of Measure: h
2.0
(2.0 to 2.0)
2.2
(2.0 to 6.0)
2.0
(2.0 to 8.0)
31.Primary Outcome
Title Tmax: Time of First Occurrence of Cmax for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 8 7
Median (Full Range)
Unit of Measure: h
2.0
(2.0 to 2.0)
2.2
(1.0 to 3.6)
2.0
(1.3 to 6.0)
32.Primary Outcome
Title AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 1
Hide Description [Not Specified]
Time Frame Cycle 1 Days 1 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM*hr
5518
(18.3%)
7095
(42.5%)
9732
(48.5%)
33.Primary Outcome
Title AUCt: Area Under the Concentration Time Curve From Time 0 to Time t for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nM*hr
16024
(20.3%)
18624
(27.3%)
17914
(48.6%)
34.Primary Outcome
Title Terminal Half-Life (t1/2) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 1 4 5
Mean (Standard Deviation)
Unit of Measure: h
13.3 [1]   (NA) 19.9  (10.7) 18.4  (13.9)
[1]
Standard deviation was not calculated for 2 participants.
35.Primary Outcome
Title Accumulation Ratio (Rac) for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 7 6
Mean (Standard Deviation)
Unit of Measure: ratio
2.9  (0.5) 2.8  (1.0) 2.3  (0.9)
36.Primary Outcome
Title Peak/Trough Ratio for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 7 7
Mean (Standard Deviation)
Unit of Measure: ratio
2.5  (0.6) 2.4  (0.5) 2.5  (2.2)
37.Primary Outcome
Title CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Enteric Coated Tablet (ECT) With Twice Daily for 7 Days (BID7D) Dosing at Day 7
Hide Description [Not Specified]
Time Frame Cycle 1 Day 7 predose and at multiple timepoints (up to 12 hours) postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK evaluable population included all participants for whom there were sufficient dosing and alisertib concentration time data to permit non-compartmental PK analysis. Here number of participants analyzed were participants evaluable for this outcome measure.
Arm/Group Title Alisertib 30 mg ECT BID 7D Alisertib 40 mg ECT BID 7D Alisertib 50 mg ECT BID 7D
Hide Arm/Group Description:
Alisertib 30 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
alisertib 40 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Alisertib 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 3 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
3.7
(0.7%)
4.4
(1.9%)
6.7
(5.6%)
38.Secondary Outcome
Title Best Overall Response Rate Based on Investigator’s Assessment
Hide Description Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions.
Time Frame Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The response-evaluable population is defined as all participants who received at least 1 dose of alisertib and have measurable disease at baseline and have at least 1 post baseline response assessment.
Arm/Group Title Part 1: PIC Dose Escalation Part 1: ECT Dose Escalation Part 2: PTCL
Hide Arm/Group Description:
Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
Overall Number of Participants Analyzed 23 23 1
Measure Type: Number
Unit of Measure: percentage of participants
13 9 100
39.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR is defined as the time from the date of first documentation of a response (either CR or PR) to the date of first documentation of progressive disease (PD) according to International Working Group (IWG) criteria. CR is defined as the disappearance of all evidence of disease and the definition for PR includes at least a 50% decrease in sum of the product of the diameters and no new lesions. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.
Time Frame Baseline and every 2 cycles up to Month 12 until disease progression, 30 days after end of treatment (up to 422 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Response-Evaluable Population who had a response of CR or PR.
Arm/Group Title Part 1: PIC Dose Escalation Part 1: ECT Dose Escalation Part 2: PTCL
Hide Arm/Group Description:
Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
Overall Number of Participants Analyzed 3 2 1
Median (Full Range)
Unit of Measure: months
0.03
(0.03 to 3.65)
2.07
(0.03 to 4.18)
0.03
(0.03 to 0.03)
40.Secondary Outcome
Title Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1
Hide Description

One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype participants for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib.

wt=wild type. *28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression. Not determined = blood sample was not evaluable.

Time Frame Cycle 1 Day 1 predose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received any amount of study drug. Data is presented for one arm because the data was collected prior to the participant receiving their assigned treatment.
Arm/Group Title Alisertib
Hide Arm/Group Description:
Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
wt/wt 23
wt/*28 23
*28/*28 8
other/other 1
Not Determined 2
Missing 1
41.Secondary Outcome
Title Number of Participants With Polymorphisms in Aurora A Kinase
Hide Description [Not Specified]
Time Frame Cycle 1 Day 1 predose
Hide Outcome Measure Data
Hide Analysis Population Description
As per protocol amendment, no data was collected for polymorphisms in Aurora A Kinase.
Arm/Group Title Alisertib
Hide Arm/Group Description:
Alisertib 25 or 35 mg, PIC formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles) followed by alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles or alisertib 40 mg, ECT formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From first dose of study drug to 30 days after the last dose (up to 422 days)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Part 1 PIC Dose Escalation Part 1 ECT Dose Escalation Part 2 PTCL
Hide Arm/Group Description Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment. Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles). Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
All-Cause Mortality
Part 1 PIC Dose Escalation Part 1 ECT Dose Escalation Part 2 PTCL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part 1 PIC Dose Escalation Part 1 ECT Dose Escalation Part 2 PTCL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/28 (42.86%)      15/28 (53.57%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Febrile neutropenia  1  1/28 (3.57%)  1 4/28 (14.29%)  5 0/2 (0.00%)  0
Thrombocytopenia  1  1/28 (3.57%)  1 1/28 (3.57%)  1 0/2 (0.00%)  0
Neutropenia  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Pancytopenia  1  0/28 (0.00%)  0 1/28 (3.57%)  2 0/2 (0.00%)  0
Cardiac disorders       
Bifascicular block  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Cardiac failure congestive  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Diarrhoea  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Small intestinal obstruction  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Stomatitis  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Abdominal pain  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
General disorders       
Systemic inflammatory response syndrome  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Asthenia  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Pyrexia  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Infections and infestations       
Septic shock  1  1/28 (3.57%)  1 1/28 (3.57%)  1 0/2 (0.00%)  0
Staphylococcal infection  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Urinary tract infection  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Pneumonia  1  0/28 (0.00%)  0 2/28 (7.14%)  3 0/2 (0.00%)  0
Cellulitis  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Staphylococcal bacteraemia  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Herpes zoster  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Bronchitis  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Lung infection  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Injury, poisoning and procedural complications       
Femur fracture  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Hypercalcaemia  1 [1]  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  2/28 (7.14%)  2 0/28 (0.00%)  0 0/2 (0.00%)  0
Back pain  1  1/28 (3.57%)  1 1/28 (3.57%)  2 0/2 (0.00%)  0
Flank pain  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Pathological fracture  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Pain in extremity  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Pain in jaw  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lymphoma  1 [2]  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Plasma cell myeloma  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Nervous system disorders       
Altered state of consciousness  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Psychiatric disorders       
Confusional state  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Delirium  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Renal and urinary disorders       
Renal failure  1 [3]  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Obstructive airways disorder  1 [3]  1/28 (3.57%)  1 0/28 (0.00%)  0 0/2 (0.00%)  0
Acute respiratory failure  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Respiratory failure  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders       
Dermatitis bullous  1  0/28 (0.00%)  0 1/28 (3.57%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0
[1]
One treatment-emergent death occurred during treatment with alisertib 50 mg and was not related.
[2]
One treatment-emergent death occurred during treatment with alisertib 90 mg and was not related.
[3]
One treatment-emergent death occurred during treatment with alisertib 65 mg and was not related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1 PIC Dose Escalation Part 1 ECT Dose Escalation Part 2 PTCL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/28 (100.00%)      28/28 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Neutropenia  1  13/28 (46.43%)  21 18/28 (64.29%)  35 2/2 (100.00%)  4
Thrombocytopenia  1  11/28 (39.29%)  14 13/28 (46.43%)  16 2/2 (100.00%)  3
Anaemia  1  11/28 (39.29%)  15 12/28 (42.86%)  18 2/2 (100.00%)  5
Leukopenia  1  4/28 (14.29%)  7 11/28 (39.29%)  22 0/2 (0.00%)  0
Lymphopenia  1  2/28 (7.14%)  3 6/28 (21.43%)  9 0/2 (0.00%)  0
Leukocytosis  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Splenomegaly  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Cardiac disorders       
Tachycardia  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Ear and labyrinth disorders       
Ear and labyrinth disorders  1  1/28 (3.57%)  1 2/28 (7.14%)  3 0/2 (0.00%)  0
Eye disorders       
Eye disorders  1  4/28 (14.29%)  5 1/28 (3.57%)  1 0/2 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea  1  9/28 (32.14%)  12 14/28 (50.00%)  20 1/2 (50.00%)  1
Nausea  1  11/28 (39.29%)  13 9/28 (32.14%)  10 0/2 (0.00%)  0
Vomiting  1  6/28 (21.43%)  7 6/28 (21.43%)  8 0/2 (0.00%)  0
Constipation  1  2/28 (7.14%)  2 5/28 (17.86%)  5 2/2 (100.00%)  2
Stomatitis  1  3/28 (10.71%)  3 2/28 (7.14%)  2 2/2 (100.00%)  2
Dry mouth  1  4/28 (14.29%)  4 1/28 (3.57%)  1 1/2 (50.00%)  1
Abdominal pain  1  2/28 (7.14%)  4 2/28 (7.14%)  2 0/2 (0.00%)  0
Dyspepsia  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Haemorrhoids  1  1/28 (3.57%)  1 0/28 (0.00%)  0 1/2 (50.00%)  1
Odynophagia  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Oral pain  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
General disorders       
Fatigue  1  10/28 (35.71%)  11 10/28 (35.71%)  13 0/2 (0.00%)  0
Oedema peripheral  1  2/28 (7.14%)  2 1/28 (3.57%)  1 1/2 (50.00%)  1
Chills  1  4/28 (14.29%)  5 1/28 (3.57%)  1 0/2 (0.00%)  0
Pyrexia  1  3/28 (10.71%)  3 3/28 (10.71%)  3 0/2 (0.00%)  0
Asthenia  1  3/28 (10.71%)  3 0/28 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations       
Upper respiratory tract infection  1  4/28 (14.29%)  4 2/28 (7.14%)  2 0/2 (0.00%)  0
Urinary tract infection  1  0/28 (0.00%)  0 3/28 (10.71%)  6 1/2 (50.00%)  1
Influenza  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Oral candidiasis  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  0/28 (0.00%)  0 1/28 (3.57%)  1 1/2 (50.00%)  1
Fall  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Post-traumatic pain  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Investigations       
Blood alkaline phosphatase increased  1  2/28 (7.14%)  2 3/28 (10.71%)  3 0/2 (0.00%)  0
Blood bilirubin increased  1  0/28 (0.00%)  0 5/28 (17.86%)  5 0/2 (0.00%)  0
White blood cell count decreased  1  1/28 (3.57%)  2 4/28 (14.29%)  5 0/2 (0.00%)  0
Alanine aminotransferase increased  1  1/28 (3.57%)  1 3/28 (10.71%)  3 0/2 (0.00%)  0
Aspartate aminotransferase increased  1  1/28 (3.57%)  1 3/28 (10.71%)  4 0/2 (0.00%)  0
Blood creatinine increased  1  2/28 (7.14%)  2 1/28 (3.57%)  1 1/2 (50.00%)  1
Blood lactate dehydrogenase increased  1  1/28 (3.57%)  1 2/28 (7.14%)  2 0/2 (0.00%)  0
Nutritional condition abnormal  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders       
Hypokalaemia  1  3/28 (10.71%)  3 7/28 (25.00%)  8 2/2 (100.00%)  2
Decreased appetite  1  6/28 (21.43%)  6 4/28 (14.29%)  4 1/2 (50.00%)  1
Hyponatraemia  1  2/28 (7.14%)  2 2/28 (7.14%)  2 0/2 (0.00%)  0
Dehydration  1  2/28 (7.14%)  2 1/28 (3.57%)  1 0/2 (0.00%)  0
Hypocalcaemia  1  1/28 (3.57%)  1 1/28 (3.57%)  1 1/2 (50.00%)  1
Hypomagnesaemia  1  0/28 (0.00%)  0 2/28 (7.14%)  2 1/2 (50.00%)  1
Hypophosphataemia  1  0/28 (0.00%)  0 3/28 (10.71%)  3 0/2 (0.00%)  0
Hypercalcaemia  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Hyperglycaemia  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Hyperuricaemia  1  1/28 (3.57%)  1 0/28 (0.00%)  0 1/2 (50.00%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/28 (7.14%)  2 3/28 (10.71%)  3 0/2 (0.00%)  0
Back pain  1  3/28 (10.71%)  3 2/28 (7.14%)  2 0/2 (0.00%)  0
Bone pain  1  2/28 (7.14%)  2 0/28 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal pain  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Nervous system disorders       
Somnolence  1  2/28 (7.14%)  2 6/28 (21.43%)  6 1/2 (50.00%)  1
Dizziness  1  0/28 (0.00%)  0 4/28 (14.29%)  5 1/2 (50.00%)  1
Headache  1  2/28 (7.14%)  2 0/28 (0.00%)  0 0/2 (0.00%)  0
Tremor  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Psychiatric disorders       
Insomnia  1  3/28 (10.71%)  3 1/28 (3.57%)  1 0/2 (0.00%)  0
Anxiety  1  1/28 (3.57%)  1 1/28 (3.57%)  1 1/2 (50.00%)  1
Depression  1  3/28 (10.71%)  3 0/28 (0.00%)  0 0/2 (0.00%)  0
Confusional state  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Mental status changes  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Panic attack  1  0/28 (0.00%)  0 0/28 (0.00%)  0 1/2 (50.00%)  1
Renal and urinary disorders       
Renal and urinary disorders  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  7/28 (25.00%)  7 4/28 (14.29%)  5 0/2 (0.00%)  0
Dyspnoea  1  6/28 (21.43%)  6 1/28 (3.57%)  1 0/2 (0.00%)  0
Rhinorrhoea  1  2/28 (7.14%)  2 1/28 (3.57%)  1 0/2 (0.00%)  0
Dyspnoea exertional  1  0/28 (0.00%)  0 2/28 (7.14%)  2 0/2 (0.00%)  0
Nasal congestion  1  2/28 (7.14%)  2 0/28 (0.00%)  0 0/2 (0.00%)  0
Sinus congestion  1  2/28 (7.14%)  2 0/28 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  5/28 (17.86%)  5 11/28 (39.29%)  11 0/2 (0.00%)  0
Pruritus  1  0/28 (0.00%)  0 4/28 (14.29%)  4 0/2 (0.00%)  0
Dermatitis  1  2/28 (7.14%)  3 0/28 (0.00%)  0 0/2 (0.00%)  0
Vascular disorders       
Hypotension  1  3/28 (10.71%)  3 2/28 (7.14%)  3 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor’s confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00697346     History of Changes
Other Study ID Numbers: C14003
U1111-1187-1184 ( Registry Identifier: WHO )
First Submitted: June 11, 2008
First Posted: June 13, 2008
Results First Submitted: January 4, 2018
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019