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Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00439270
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : November 27, 2013
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Prostate Cancer
Interventions Drug: Dasatinib
Drug: Docetaxel
Enrollment 49
Recruitment Details  
Pre-assignment Details A total of 49 participants were enrolled in the study, and 46 entered the treatment period and received at least 1 dose of dasatinib.
Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Period Title: Phase 1 (18.1 Months)
Started 3 [1] 3 [1] 3 [1] 4 [1] 3 [1]
Completed 0 [2] 0 [2] 0 [2] 4 [2] 0 [2]
Not Completed 3 3 3 0 3
Reason Not Completed
Disease progression             3             2             3             0             3
Study drug toxicity             0             1             0             0             0
[1]
Participants who received treatment
[2]
Remained on study
Period Title: Phase 2 (51.6 Months)
Started 0 0 0 34 [1] 0
Completed 0 0 0 0 0
Not Completed 0 0 0 34 0
Reason Not Completed
Disease progression             0             0             0             18             0
Poor compliance/noncompliance             0             0             0             1             0
Study drug toxicity             0             0             0             6             0
Maximum clinical benefit             0             0             0             3             0
No longer meets study criteria             0             0             0             1             0
Withdrawal by Subject             0             0             0             2             0
Adverse event unrelated to study drug             0             0             0             2             0
Insurance no longer covered patient care             0             0             0             1             0
[1]
Includes 4 patients who completed Phase 1
Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Total
Hide Arm/Group Description Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm. Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 34 3 46
Hide Baseline Analysis Population Description
All patients who received at least 1 dose of dasatinib
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 34 participants 3 participants 46 participants
<65 years 0 1 1 19 2 23
>=65 years 3 2 2 15 1 23
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 34 participants 3 participants 46 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
3
 100.0%
34
 100.0%
3
 100.0%
46
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 34 participants 3 participants 46 participants
Black or African American 0 0 0 4 0 4
White 3 3 3 29 3 41
Other 0 0 0 1 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 34 participants 3 participants 46 participants
Hispanic/Latino 0 0 0 1 0 1
Not Hispanic/Latino 3 3 3 33 3 45
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Dasatinib Administered With Docetaxel
Hide Description MTD was defined by dose-limiting toxicity (DLT) criteria. DLT was defined as grade 4 neutropenia causing treatment interruption for >14 days, febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with a bleeding episode requiring platelet transfusion, nausea and/or vomiting despite medical intervention/prophylaxis causing treatment interruption for >14 days, grade 3-4 asthenia/fatigue, any other grade >=3 nonhematologic toxicity except alopecia or transient arthralgia/myalgia (unless unresponsive to intervention), or interruption of study drug for >14 days due to toxicity. When defined, the MTD would serve as recommended Phase 2 dose of each drug in the combination of oral dasatinib and intravenous docetaxel.
Time Frame From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of dasatinib in Phase 1
Arm/Group Title All Treated (Phase 1)
Hide Arm/Group Description:
Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: mg
NA [1] 
[1]
Because no DLT occurred, MTD was not determined. Recommended Phase 2 dasatinib dose based on ongoing studies in chronic myelogenous leukemia and previous study in chronic refractory prostate cancer. Recommended docetaxel dose based on package insert.
2.Primary Outcome
Title Recommended Phase 2 Dose of Dasatinib Administered With Docetaxel, 75 mg/m^2
Hide Description Because no dose-limiting toxicities occurred, the recommended dose of dasatinib used in Phase 2 was based on findings from ongoing studies in chronic myelogenous leukemia and experience from the previous Phase 2 study of single-agent dasatinib in chronic refractory prostate cancer. The recommended Phase 2 dose of docetaxel (75 mg/m^2) was based on the docetaxel package insert.
Time Frame From Day 3 of first 21-day cycle to Cycle 2 , Day 21 (or Study Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of dasatinib in Phase 1
Arm/Group Title All Treated (Phase 1)
Hide Arm/Group Description:
Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: mg
100
3.Secondary Outcome
Title Percentage of Participants With a Prostate Specific Antigen (PSA) Response
Hide Description PSA response rate is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements
Time Frame At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment (up to 51.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
64.7
(46.49 to 80.25)
4.Secondary Outcome
Title Duration of Prostate Specific Antigen (PSA) Response
Hide Description Duration of response is computed for participants with confirmed PSA response. It is measured in months from the time of the first of 2 consecutive measurements meeting the criteria for confirmed PSA response to the date of the first of 3 consecutive measurements that confirm PSA progression, the date of disease progression, or the date of death. Participants who neither progressed (PSA or disease) nor died were censored on the date of their last PSA assessment. PSA response is defined as a decrease of >=50% in PSA levels from baseline, sustained for at least 6 weeks and confirmed by at least 2 measurements. PSA progression is defined as 3 consecutive increases in PSA from baseline or nadir, each measurement at least 1 week apart. The final confirming PSA measurement had to be ≥5ng/mL higher than baseline or nadir and also represent at least a 50% increase from baseline or nadir (ie, the value is ≥1.5*baseline or nadir PSA).
Time Frame At pretreatment visit, and on Day 1 of Cycles 2 through 12, then every other cycle, where investigator deems appropriate, and at end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received dasatinib, 100 mg + docetaxel, 75 mg/m^2 and who had a PSA response
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: Months
9.5
(7.1 to 25.2)
5.Secondary Outcome
Title Number of Months of Progression-free Survival (PFS)
Hide Description

PFS defined as time in months from the first dosing date to the date of disease progression or the date of death. Patients who neither progressed nor died were censored on the date of their last on-study prostate specific antigen (PSA) measurement, tumor assessment, or radionuclide bone scan assessment (whichever occurred last). Disease progression defined as either of the following: progression on radionuclide bone scan, death, or at least 2 of the following:

tumor progression, as defined by modified Response Evaluation Criteria in Solid Tumors; PSA progression; or investigator-defined clinical progression based on physical examination, history, symptoms, and performance status.

Time Frame Patients with an event: time from first dose to disease progression or death, whichever occurs first. Patients without an event: time to last on-study PSA measurement, tumor assessment, or radionuclide bone scan assessment, whichever occurs last
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: Months
11.5
(8.8 to 18.9)
6.Secondary Outcome
Title Percentage of Participants With an Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Objective response rate is defined as the percentage of participants who have achieved best responses of confirmed Complete Response (CR) or Partial Response (PR) where confirmed requires repeat evaluations for a minimum of 4 weeks after the criteria for response are first met. RECIST: CR=disappearance of clinical and radiologic evidence of target lesions; PR=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD.
Time Frame Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
44.1
(27.19 to 62.11)
7.Secondary Outcome
Title Number of Participants by Best On-study Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description

RECIST for target lesions: Complete Response (CR)=disappearance of clinical and radiologic evidence of target lesions. Partial Response (PR)=a 30% or greater decrease in the sum of the longest diameter (LD) of all lesions in reference to the baseline sum LD. Stable disease (SD)=neither sufficient increase to qualify for Progressive Disease (PD) nor sufficient shrinkage to qualify for PR.

PD=a 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline; unequivocal progression of nonmeasurable disease/lesions as evaluated by CT scan or MRI (not as evaluated by radionuclide bone scan) and/or new lesions are present.

To qualify as SD, patients had to exhibit SD for a minimum of 18 weeks. Those with evaluations noted as SD prior to 18 weeks and discontinued were reported as no change.

Time Frame Pretreatment visit then every 6 weeks thereafter (up to 51.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
Complete response 0
Partial response 15
Stable disease 1
No change 3
Progressive disease 2
Not evaluable 13
8.Secondary Outcome
Title Number of Participants by Best On-study Bone Scan Assessment From Baseline
Hide Description Stable=no new lesions appeared at any 6-week assessment or new pain was not developed in an area that was previously visualized for a minimum of 18 weeks; no change=stable disease prior to 18 weeks and then discontinued treatment; progression=2 or more new areas of focal uptake or new adverse clinical symptoms in an area previously visualized; improved=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized.
Time Frame From Day 1 of therapy to last bone scan assessment (up to 51.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
Improved 8
Stable 17
No change 7
Progression 1
Not evaluable 1
9.Secondary Outcome
Title Percentage of Participants With Improvement on Bone Scan
Hide Description Improvement=disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, and new pain not developing in an area that was previously visualized
Time Frame From Day 1 of therapy to last bone scan assessment (up to 51.6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
23.5
(10.75 to 41.17)
10.Secondary Outcome
Title Baseline Scores and Changes in Pain Intensity From Baseline on the Brief Pain Inventory Short Form (BPI-sf) Scores Through Cycle 6
Hide Description The BPI-sf assessed intensity of pain in the last 24 hours as well as impact of pain on daily functions. Patients rated the severity of their pain at its worst, least, and average in the last 24 hours using an 11-point rating scale with endpoints of no pain (0 points) and pain as bad as you can imagine (11 points). They were asked to rate their present pain and pain at the time they completed the BPI-sf. Using an 11-point rating scale with endpoints of does not interfere (0 points) and completely interferes (11 points), the BPI-sf similarly assessed to what extent pain interfered with mood, walking, general activity, work, relations with others, sleep, and enjoyment of life. The BPI-sf also asked patients to mark the location of their pain on a body drawing and included other questions about pain treatment and the extent of pain relief. The BPI-sf was collected in the Phase 2 portion of the study only. For on-treatment visits, the BPI-sf was completed prior to the docetaxel infusion.
Time Frame At pretreatment visit and on Day 1 of Cycles 2 through 6, then Day 1 of every other cycle, at end of treatment, and at follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2, in the Phase 2 portion of the study and completed the BPI-sf at baseline. n=evaluable participants in that cycle.
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: Units on a scale
Baseline: Average of pain (n=18)
1.0
(1.0 to 5.8)
Baseline: Average of pain interference (n=18)
1.0
(0.0 to 7.3)
Cycle 2: Average of pain (n=11)
-0.8
(-2.3 to 0.8)
Cycle 2: Average of pain interference (n=11)
0.0
(-2.3 to 1.0)
Cycle 3: Average of pain (n=7)
-0.5
(-2.0 to 0.8)
Cycle 3: Average of pain interference (n=7)
-0.0
(-3.0 to 1.7)
Cycle 4: Average of pain (n=10)
-1.0
(-1.5 to 0.0)
Cycle 4: Average of pain interference (n=10)
-0.1
(-1.0 to 1.6)
Cycle 5: Average of pain (n=5)
-0.8
(-1.5 to 2.5)
Cycle 5: Average of pain interference (n=5)
0.0
(-0.6 to 4.6)
Cycle 6: Average of pain (n=9)
-0.8
(-1.5 to 0.9)
Cycle 6: Average of pain interference (n=9)
0.0
(-1.0 to 4.0)
11.Secondary Outcome
Title Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Overall Population
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.
Time Frame From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of dasatinib
Arm/Group Title All Treated
Hide Arm/Group Description:
Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: Participants
Deaths 3
SAEs 17
Drug-related SAEs 8
Drug-related AEs 45
Drug-related AEs leading to discontinuation 7
Drug-related Grade 3 or 4 AEs 13
12.Secondary Outcome
Title Number of Participants With Death as Outcome, Drug-related Serious Adverse Events (SAEs), Drug-related Adverse Events (AEs), Drug-related AEs Leading to Discontinuation, and Drug-related Grade 3 or 4 AEs in the Phase 2 Cohort
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Leading to death.
Time Frame From first dose Day 1 through at least 30 days after last dose of either dasatinib or docetaxel, whichever was later (up to approximately 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received dasatinib, 100 mg + docetaxel, 75 mg/m^2
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
Deaths 2
Drug-related SAEs 7
Drug-related AEs 33
Drug-related AEs leading to discontinuation 6
Drug-related Grade 3 or 4 AEs 12
13.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) From 0 to 10 Hours Postdose (AUC [0-10])and AUC in 1 Dosing Interval, From Time 0 to 24 Hours (AUC[Tau])of Dasatinib Coadministered With Docetaxel
Hide Description [Not Specified]
Time Frame Cycle 1, Day 14 at 0, 0.5 , 1, 2, 3, 4, 7, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable
Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Overall Number of Participants Analyzed 3 3 3 34 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng.h/mL
AUC(0-10) (n=3, 1, 3, 28, 3)
173.13
(54%)
71.75 [1] 
(NA%)
149.79
(26%)
277.07
(54%)
461.82
(35%)
AUC(tau) (n=3, 1, 3, 21, 3)
205.43
(57%)
82.20 [1] 
(NA%)
200.63
(25%)
389.66
(48%)
556.47
(36%)
[1]
Insufficient participants with events
14.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Dasatinib and of Docetaxel
Hide Description [Not Specified]
Time Frame Docetaxel: Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose; dasatanib: Cycle 1, Day 14 at 0, .5, 1, 2, 3, 4, 7, 10, and 24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of dasatinib; n=number of patients who were evaluable
Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Overall Number of Participants Analyzed 3 3 3 34 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Dasatinib (n=3, 1, 3, 29, 3)
42.70
(68%)
21.99 [1] 
(NA%)
30.00
(17%)
83.91
(74%)
164.99
(26%)
Docetaxel (n=3, 3, 3, 34, 3)
2226.25
(46%)
1763.34
(25%)
1748.43
(20%)
2125.49
(33%)
2412.41
(14%)
[1]
Insufficient participants with events
15.Secondary Outcome
Title Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity (AUC[Inf]) of Docetaxel
Hide Description [Not Specified]
Time Frame Cycle 1, Day 1 at 0, 0.5, 1, 1.25, 1.5, 2, 3, 4, 7, 10, 24, and 48 hours postdose
Hide Outcome Measure Data
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All patients who received at least 1 dose of dasatinib
Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Overall Number of Participants Analyzed 3 3 3 34 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng.h/mL
3085.59
(54%)
2064.49
(24%)
2113.37
(23%)
2663.83
(33%)
3283.27
(19%)
16.Secondary Outcome
Title Number of Participants Meeting the Criteria for On-study Abnormal Results Grade 3-4 of Clinical Laboratory Tests
Hide Description ULN=upper limit of normal. Graded by Common Toxicity Criteria: 1 (least severe) to 4 (life threatening ). Absolute neutrophil count (*10^9/L), Grade 3, <1.0-0.5; Grade 4, <0.5. Hemoglobin (mmol/L), Grade 3, <4.9-4.0; Grade 4, <4.0. Platelets (*10^9/L), Grade 3, <50.0-25.0; Grade 4, <25.0. Leukocytes (*10^9/L) Grade 3, <2.0-1.0; Grade 4, <1.0. ALP, ALT, and AST (*ULN), Grade 3, >5.0-20.0; Grade 4, >20.0. Total bilirubin (*ULN), Grade 3, >3.0-10.0; Grade 4, >10.0. Creatinine (*ULN), Grade 3, >3.0-6.0; Grade 4, >6.0. Hypercalcemia (mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3. Prothrombin time (seconds), Grade 3, >2.0; Grade 4, not defined.
Time Frame From Day 2 of Cycle 1 to up to 30 days after last dose of study drug (up to approximately 49 months)
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All participants who received at least 1 dose of study drug
Arm/Group Title Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2 Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description:
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
Overall Number of Participants Analyzed 3 3 3 34 3
Measure Type: Number
Unit of Measure: Participants
Absolute neutrophil count 0 0 0 1 0
Hemoglobin 0 0 0 0 0
Platelet count 0 0 0 0 0
Leukocytes 0 0 0 0 0
Alanine aminotransferase (ALT) 0 0 0 0 0
Aspartate aminotransferase (AST) 0 0 0 0 0
Alkaline phosphatase (ALP) 1 1 0 1 0
Total bilirubin 0 0 0 0 0
Hypercalcemia 0 0 0 0 0
Hypocalcemia 0 0 0 1 0
Creatinine 0 0 0 0 0
Hyperkalemia 0 0 0 1 0
Hypokalemia 0 0 0 0 1
Hypernatremia 0 0 0 0 0
Hyponatremia 0 0 0 2 0
Phosphorus, inorganic 0 1 0 1 0
Prothrombin time 0 0 0 0 0
Time Frame From 1st dose, Day 1 to up to 30 days after last dose of study drug (approximately 49 months + 30 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Hide Arm/Group Description Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
All-Cause Mortality
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/34 (41.18%)   1/3 (33.33%)   1/3 (33.33%)   0/3 (0.00%)   1/3 (33.33%) 
Blood and lymphatic system disorders           
Leukopenia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neutropenia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Anaemia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Febrile neutropenia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cardiac disorders           
Atrial fibrillation  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cardiac failure congestive  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Diastolic dysfunction  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders           
Constipation  1  0/34 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Abdominal pain  1  0/34 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
General disorders           
Mucosal inflammation  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Fatigue  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pyrexia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Asthenia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Immune system disorders           
Drug hypersensitivity  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Infections and infestations           
Bronchitis  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cellulitis  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Subcutaneous abscess  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pneumonia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Sepsis  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Gastroenteritis viral  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Infection  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Bone pain  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Spinal column stenosis  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal pain  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasm malignant  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Nervous system disorders           
Syncope  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Spinal cord compression  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cerebral ischaemia  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Psychiatric disorders           
Confusional state  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders           
Renal failure acute  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pneumonitis  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Chronic obstructive pulmonary disease  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Aspiration  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pleural effusion  1  4/34 (11.76%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pulmonary embolism  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Vascular disorders           
Hypotension  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 Dasatinib, 120 mg + Docetaxel, 75 mg/m^2 Dasatinib, 50 mg + Docetaxel, 60 mg/m^2 Dasatinib, 50 mg + Docetaxel, 75 mg/m^2 Dasatinib, 70 mg + Docetaxel, 75 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/34 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders           
Leukopenia  1  0/34 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Granulocytopenia  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Anaemia  1  10/34 (29.41%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Cardiac disorders           
Atrial fibrillation  1  2/34 (5.88%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Tachycardia  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Angina pectoris  1  0/34 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Ear and labyrinth disorders           
Tinnitus  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Eye disorders           
Dry eye  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Eye pain  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Lacrimation increased  1  4/34 (11.76%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Vision blurred  1  2/34 (5.88%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders           
Vomiting  1  9/34 (26.47%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Oral pain  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Constipation  1  9/34 (26.47%)  2/3 (66.67%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%) 
Abdominal pain lower  1  0/34 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Nausea  1  20/34 (58.82%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Dyspepsia  1  5/34 (14.71%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Mouth ulceration  1  0/34 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Stomatitis  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Ascites  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Diarrhoea  1  25/34 (73.53%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Gastrooesophageal reflux disease  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Rectal haemorrhage  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
General disorders           
Face oedema  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Pain  1  6/34 (17.65%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Fatigue  1  27/34 (79.41%)  1/3 (33.33%)  3/3 (100.00%)  1/3 (33.33%)  3/3 (100.00%) 
Pyrexia  1  6/34 (17.65%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Asthenia  1  5/34 (14.71%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Oedema  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Chest pain  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Chills  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Influenza like illness  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Injection site reaction  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Oedema peripheral  1  14/34 (41.18%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Immune system disorders           
Hypersensitivity  1  4/34 (11.76%)  0/3 (0.00%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%) 
Infections and infestations           
Bronchitis  1  0/34 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Sinusitis  1  4/34 (11.76%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Urinary tract infection  1  6/34 (17.65%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Localised infection  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Rhinitis  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Tinea cruris  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Infection  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Upper respiratory tract infection  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications           
Laceration  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Contusion  1  4/34 (11.76%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Fall  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Rib fracture  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Investigations           
Blood lactate dehydrogenase increased  1  1/34 (2.94%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Weight decreased  1  5/34 (14.71%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Alanine aminotransferase increased  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood uric acid increased  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Cardiac murmur  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Haemoglobin decreased  1  3/34 (8.82%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Blood creatinine increased  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Blood urea increased  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Electrocardiogram QT prolonged  1  0/34 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Weight increased  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Activated partial thromboplastin time shortened  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Metabolism and nutrition disorders           
Hypoalbuminaemia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hypocalcaemia  1  1/34 (2.94%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hypokalaemia  1  4/34 (11.76%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hyperglycaemia  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Hyponatraemia  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Decreased appetite  1  17/34 (50.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Hypophosphataemia  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Dehydration  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  5/34 (14.71%)  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Bone pain  1  4/34 (11.76%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Neck pain  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pain in extremity  1  6/34 (17.65%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Muscular weakness  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Arthralgia  1  9/34 (26.47%)  2/3 (66.67%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%) 
Musculoskeletal chest pain  1  2/34 (5.88%)  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Myalgia  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Flank pain  1  0/34 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal pain  1  2/34 (5.88%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Seborrhoeic keratosis  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Nervous system disorders           
Headache  1  6/34 (17.65%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypoaesthesia  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neuropathy peripheral  1  6/34 (17.65%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Dysgeusia  1  17/34 (50.00%)  2/3 (66.67%)  2/3 (66.67%)  0/3 (0.00%)  1/3 (33.33%) 
Dizziness  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/3 (66.67%) 
Peripheral sensory neuropathy  1  4/34 (11.76%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Psychiatric disorders           
Insomnia  1  6/34 (17.65%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Depression  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Anxiety  1  4/34 (11.76%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders           
Incontinence  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Urinary hesitation  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Urinary retention  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Urethral pain  1  0/34 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Urinary bladder haemorrhage  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pollakiuria  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Proteinuria  1  1/34 (2.94%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Urinary incontinence  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  16/34 (47.06%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Epistaxis  1  3/34 (8.82%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Apnoea  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pneumonitis  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Chronic obstructive pulmonary disease  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cough  1  7/34 (20.59%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Productive cough  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Pleural effusion  1  8/34 (23.53%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders           
Nail disorder  1  8/34 (23.53%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Dry skin  1  8/34 (23.53%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Ecchymosis  1  2/34 (5.88%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Erythema  1  2/34 (5.88%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Rash  1  5/34 (14.71%)  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Alopecia  1  25/34 (73.53%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Vascular disorders           
Thrombosis  1  0/34 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Hot flush  1  5/34 (14.71%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Hypertension  1  1/34 (2.94%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Flushing  1  2/34 (5.88%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Hypotension  1  1/34 (2.94%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00439270     History of Changes
Other Study ID Numbers: CA180-086
First Submitted: February 22, 2007
First Posted: February 23, 2007
Results First Submitted: June 25, 2013
Results First Posted: November 27, 2013
Last Update Posted: March 28, 2014