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Trial record 4 of 59 for:    MLN8237

Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas

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: NCT01898078
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Solid Tumors
Lymphoma
Intervention Drug: Alisertib
Enrollment 26
Recruitment Details Participants took part in the study at 3 investigative sites in the United States from 16 July 2013 to 24 January 2017. Data cut-off for the primary analysis was 05 March 2014.
Pre-assignment Details Participants with a diagnosis of advanced solid tumors or lymphomas were enrolled to crossover fashion to receive alisertib 50 mg enteric-coated tablet (ECT), orally in fasted or fed state in Cycles 1 and 2.
Arm/Group Title Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Hide Arm/Group Description Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity. Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Period Title: Overall Study
Started 13 13
Completed 7 [1] 5 [1]
Not Completed 6 8
Reason Not Completed
Progressive Disease             1             5
Adverse Event             2             1
Withdrawal by Subject             1             1
Symptomatic Deterioration             2             0
Reason not Specified             0             1
[1]
Completed treatment
Arm/Group Title Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed Total
Hide Arm/Group Description Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity. Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity. Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
59.6  (10.15) 61.7  (12.64) 60.7  (11.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
6
  46.2%
7
  53.8%
13
  50.0%
Male
7
  53.8%
6
  46.2%
13
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Hispanic or Latino
5
  38.5%
4
  30.8%
9
  34.6%
Not Hispanic or Latino
8
  61.5%
9
  69.2%
17
  65.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
White
10
  76.9%
13
 100.0%
23
  88.5%
Black or African American
3
  23.1%
0
   0.0%
3
  11.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13
 100.0%
13
 100.0%
26
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 13 participants 13 participants 26 participants
166.9  (14.34) 165.3  (11.32) 166.1  (12.68)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 13 participants 26 participants
73.59  (15.484) 78.37  (20.183) 75.98  (17.792)
1.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration of Alisertib
Hide Description [Not Specified]
Time Frame Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.
Arm/Group Title Alisertib 50 mg Fed Alisertib 50 mg Fasted
Hide Arm/Group Description:
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: nM
1338.6  (487.25) 1354.5  (432.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alisertib 50 mg Fed, Alisertib 50 mg Fasted
Comments The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
0.85 to 1.12
Estimation Comments Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.
2.Primary Outcome
Title AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib
Hide Description [Not Specified]
Time Frame Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.
Arm/Group Title Alisertib 50 mg Fed Alisertib 50 mg Fasted
Hide Arm/Group Description:
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: hr*nM
24645.5  (12467.39) 20797.7  (8847.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alisertib 50 mg Fed, Alisertib 50 mg Fasted
Comments The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Ratio
Estimated Value 1.16
Confidence Interval (2-Sided) 90%
1.01 to 1.34
Estimation Comments Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.
3.Primary Outcome
Title AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib
Hide Description [Not Specified]
Time Frame Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters. Here, number of participants analysed are the participants who were evaluable for this outcome measure.
Arm/Group Title Alisertib 50 mg Fed Alisertib 50 mg Fasted
Hide Arm/Group Description:
Alisertib 50 mg, ECT, orally, in fed state, once on Day 1 in Cycles 1 and 2.
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1 in Cycles 1 and 2.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: hr*nM
24537.5  (9882.10) 22771.4  (10206.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alisertib 50 mg Fed, Alisertib 50 mg Fasted
Comments The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Ratio
Estimated Value 1.15
Confidence Interval (2-Sided) 90%
0.96 to 1.39
Estimation Comments Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.
4.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description

An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Time Frame From first dose through 30 days after the last dose of study drug (up to 225 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
Arm/Group Title Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Hide Arm/Group Description:
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
13
 100.0%
13
 100.0%
SAEs
7
  53.8%
7
  53.8%
5.Secondary Outcome
Title Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs
Hide Description The number of participants with any clinical significant change in safety laboratory values collected throughout the study.
Time Frame From first dose through 30 days after the last dose of study drug (up to 225 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
Arm/Group Title Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Hide Arm/Group Description:
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenia
10
  76.9%
8
  61.5%
Anaemia
5
  38.5%
3
  23.1%
Leukopenia
5
  38.5%
2
  15.4%
Thrombocytopenia
1
   7.7%
2
  15.4%
Hypokalaemia
0
   0.0%
3
  23.1%
Hyperbilirubinaemia
1
   7.7%
1
   7.7%
Neutrophil count decreased
1
   7.7%
1
   7.7%
Lymphopenia
0
   0.0%
1
   7.7%
Hyperkalaemia
1
   7.7%
0
   0.0%
Hypomagnesaemia
0
   0.0%
1
   7.7%
Aspartate aminotransferase increased
0
   0.0%
1
   7.7%
Blood bilirubin increased
1
   7.7%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs
Hide Description The number of participants with any clinical significant change in vital signs (sitting diastolic and systolic blood pressure, heart rate, and temperature) were collected throughout the study.
Time Frame From first dose through 30 days after the last dose of study drug (up to 225 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
Arm/Group Title Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Hide Arm/Group Description:
Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
Overall Number of Participants Analyzed 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Hypertension
0
   0.0%
1
   7.7%
Hypotension
0
   0.0%
1
   7.7%
Tachycardia
0
   0.0%
1
   7.7%
Time Frame From first dose through 30 days after the last dose of study drug (up to 225 days)
Adverse Event Reporting Description According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.
 
Arm/Group Title Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Hide Arm/Group Description Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity. Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.
All-Cause Mortality
Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   1/13 (7.69%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Affected / at Risk (%) Affected / at Risk (%)
Total   7/13 (53.85%)   7/13 (53.85%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/13 (7.69%)  0/13 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/13 (15.38%)  1/13 (7.69%) 
Rectal haemorrhage  1 [1]  0/13 (0.00%)  1/13 (7.69%) 
Nausea  1  0/13 (0.00%)  1/13 (7.69%) 
Vomiting  1  0/13 (0.00%)  1/13 (7.69%) 
General disorders     
Pyrexia  1  1/13 (7.69%)  0/13 (0.00%) 
Non-cardiac chest pain  1  0/13 (0.00%)  1/13 (7.69%) 
Infections and infestations     
Cellulitis  1  0/13 (0.00%)  1/13 (7.69%) 
Bacteraemia  1  1/13 (7.69%)  0/13 (0.00%) 
Pneumonia streptococcal  1  1/13 (7.69%)  0/13 (0.00%) 
Pyelonephritis  1  0/13 (0.00%)  1/13 (7.69%) 
Streptococcal sepsis  1  1/13 (7.69%)  0/13 (0.00%) 
Injury, poisoning and procedural complications     
Pneumothorax traumatic  1  1/13 (7.69%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  0/13 (0.00%)  1/13 (7.69%) 
Back pain  1  0/13 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Toxic encephalopathy  1  1/13 (7.69%)  0/13 (0.00%) 
Psychiatric disorders     
Delirium  1  0/13 (0.00%)  1/13 (7.69%) 
Mental status changes  1  1/13 (7.69%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  1/13 (7.69%)  0/13 (0.00%) 
Pulmonary embolism  1  0/13 (0.00%)  1/13 (7.69%) 
1
Term from vocabulary, MedDRA version 19.0
Indicates events were collected by systematic assessment
[1]
One treatment emergent death occurred during treatment with Alisertib 50 mg Fasted + Fed arm and is not related to the study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alisertib 50 mg Fed + Fasted Alisertib 50 mg Fasted + Fed
Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   13/13 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  11/13 (84.62%)  8/13 (61.54%) 
Anaemia  1  6/13 (46.15%)  4/13 (30.77%) 
Leukopenia  1  5/13 (38.46%)  3/13 (23.08%) 
Thrombocytopenia  1  2/13 (15.38%)  3/13 (23.08%) 
Lymphopenia  1  0/13 (0.00%)  1/13 (7.69%) 
Cardiac disorders     
Tachycardia  1  0/13 (0.00%)  1/13 (7.69%) 
Ear and labyrinth disorders     
Ear pain  1  0/13 (0.00%)  1/13 (7.69%) 
Hypoacusis  1  0/13 (0.00%)  1/13 (7.69%) 
Eye disorders     
Cataract  1  2/13 (15.38%)  0/13 (0.00%) 
Eyelid cyst  1  1/13 (7.69%)  0/13 (0.00%) 
Gastrointestinal disorders     
Stomatitis  1  3/13 (23.08%)  8/13 (61.54%) 
Vomiting  1  3/13 (23.08%)  7/13 (53.85%) 
Diarrhoea  1  5/13 (38.46%)  4/13 (30.77%) 
Nausea  1  2/13 (15.38%)  5/13 (38.46%) 
Abdominal pain  1  2/13 (15.38%)  2/13 (15.38%) 
Abdominal pain upper  1  0/13 (0.00%)  3/13 (23.08%) 
Abdominal pain lower  1  1/13 (7.69%)  1/13 (7.69%) 
Constipation  1  1/13 (7.69%)  1/13 (7.69%) 
Dysphagia  1  1/13 (7.69%)  1/13 (7.69%) 
Gastrooesophageal reflux disease  1  0/13 (0.00%)  2/13 (15.38%) 
Abdominal distension  1  0/13 (0.00%)  1/13 (7.69%) 
Ascites  1  0/13 (0.00%)  1/13 (7.69%) 
Diverticulum  1  0/13 (0.00%)  1/13 (7.69%) 
Dry mouth  1  0/13 (0.00%)  1/13 (7.69%) 
Faeces discoloured  1  0/13 (0.00%)  1/13 (7.69%) 
Haematemesis  1  0/13 (0.00%)  1/13 (7.69%) 
Haemorrhoids  1  0/13 (0.00%)  1/13 (7.69%) 
Inguinal hernia  1  1/13 (7.69%)  0/13 (0.00%) 
Oesophageal stenosis  1  0/13 (0.00%)  1/13 (7.69%) 
Swollen tongue  1  0/13 (0.00%)  1/13 (7.69%) 
General disorders     
Fatigue  1  8/13 (61.54%)  3/13 (23.08%) 
Pyrexia  1  1/13 (7.69%)  5/13 (38.46%) 
Asthenia  1  1/13 (7.69%)  3/13 (23.08%) 
Oedema peripheral  1  1/13 (7.69%)  2/13 (15.38%) 
Chills  1  1/13 (7.69%)  1/13 (7.69%) 
Local swelling  1  2/13 (15.38%)  0/13 (0.00%) 
Catheter site erythema  1  1/13 (7.69%)  0/13 (0.00%) 
Catheter site haemorrhage  1  1/13 (7.69%)  0/13 (0.00%) 
Catheter site pain  1  1/13 (7.69%)  0/13 (0.00%) 
Infusion site vesicles  1  1/13 (7.69%)  0/13 (0.00%) 
Localised oedema  1  0/13 (0.00%)  1/13 (7.69%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/13 (7.69%)  1/13 (7.69%) 
Infections and infestations     
Urinary tract infection  1  2/13 (15.38%)  1/13 (7.69%) 
Sinusitis  1  1/13 (7.69%)  1/13 (7.69%) 
Bronchitis  1  0/13 (0.00%)  1/13 (7.69%) 
Candida infection  1  0/13 (0.00%)  1/13 (7.69%) 
Cystitis  1  0/13 (0.00%)  1/13 (7.69%) 
Genital herpes  1  0/13 (0.00%)  1/13 (7.69%) 
Lung abscess  1  1/13 (7.69%)  0/13 (0.00%) 
Nasopharyngitis  1  0/13 (0.00%)  1/13 (7.69%) 
Oral candidiasis  1  0/13 (0.00%)  1/13 (7.69%) 
Oral herpes  1  0/13 (0.00%)  1/13 (7.69%) 
Upper respiratory tract infection  1  0/13 (0.00%)  1/13 (7.69%) 
Vaginitis bacterial  1  0/13 (0.00%)  1/13 (7.69%) 
Injury, poisoning and procedural complications     
Fall  1  2/13 (15.38%)  2/13 (15.38%) 
Contusion  1  1/13 (7.69%)  1/13 (7.69%) 
Femur fracture  1  1/13 (7.69%)  0/13 (0.00%) 
Fibula fracture  1  0/13 (0.00%)  1/13 (7.69%) 
Ligament sprain  1  0/13 (0.00%)  1/13 (7.69%) 
Investigations     
Aspartate aminotransferase increased  1  1/13 (7.69%)  1/13 (7.69%) 
Neutrophil count decreased  1  1/13 (7.69%)  1/13 (7.69%) 
Alanine aminotransferase increased  1  1/13 (7.69%)  0/13 (0.00%) 
Blood bilirubin increased  1  1/13 (7.69%)  0/13 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/13 (23.08%)  4/13 (30.77%) 
Dehydration  1  1/13 (7.69%)  2/13 (15.38%) 
Hypokalaemia  1  0/13 (0.00%)  3/13 (23.08%) 
Hypomagnesaemia  1  1/13 (7.69%)  1/13 (7.69%) 
Hyperglycaemia  1  1/13 (7.69%)  0/13 (0.00%) 
Hyperkalaemia  1  1/13 (7.69%)  0/13 (0.00%) 
Hypoalbuminaemia  1  0/13 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/13 (15.38%)  2/13 (15.38%) 
Musculoskeletal chest pain  1  2/13 (15.38%)  1/13 (7.69%) 
Pain in extremity  1  2/13 (15.38%)  1/13 (7.69%) 
Arthralgia  1  0/13 (0.00%)  2/13 (15.38%) 
Joint swelling  1  1/13 (7.69%)  1/13 (7.69%) 
Muscle spasms  1  2/13 (15.38%)  0/13 (0.00%) 
Musculoskeletal pain  1  1/13 (7.69%)  1/13 (7.69%) 
Myalgia  1  0/13 (0.00%)  2/13 (15.38%) 
Costochondritis  1  1/13 (7.69%)  0/13 (0.00%) 
Flank pain  1  0/13 (0.00%)  1/13 (7.69%) 
Groin pain  1  1/13 (7.69%)  0/13 (0.00%) 
Inguinal mass  1  0/13 (0.00%)  1/13 (7.69%) 
Muscular weakness  1  1/13 (7.69%)  0/13 (0.00%) 
Neck pain  1  0/13 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Dizziness  1  2/13 (15.38%)  3/13 (23.08%) 
Headache  1  1/13 (7.69%)  2/13 (15.38%) 
Somnolence  1  2/13 (15.38%)  1/13 (7.69%) 
Neuropathy peripheral  1  2/13 (15.38%)  0/13 (0.00%) 
Memory impairment  1  1/13 (7.69%)  0/13 (0.00%) 
Metabolic encephalopathy  1  1/13 (7.69%)  0/13 (0.00%) 
Peripheral sensory neuropathy  1  1/13 (7.69%)  0/13 (0.00%) 
Psychiatric disorders     
Confusional state  1  2/13 (15.38%)  2/13 (15.38%) 
Anxiety  1  1/13 (7.69%)  0/13 (0.00%) 
Hallucination  1  1/13 (7.69%)  0/13 (0.00%) 
Hallucination, auditory  1  0/13 (0.00%)  1/13 (7.69%) 
Insomnia  1  1/13 (7.69%)  0/13 (0.00%) 
Mental status changes  1  0/13 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders     
Pollakiuria  1  1/13 (7.69%)  1/13 (7.69%) 
Urinary incontinence  1  0/13 (0.00%)  2/13 (15.38%) 
Micturition urgency  1  0/13 (0.00%)  1/13 (7.69%) 
Urinary hesitation  1  1/13 (7.69%)  0/13 (0.00%) 
Reproductive system and breast disorders     
Vaginal discharge  1  1/13 (7.69%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/13 (15.38%)  3/13 (23.08%) 
Dyspnoea exertional  1  1/13 (7.69%)  3/13 (23.08%) 
Sinus congestion  1  1/13 (7.69%)  3/13 (23.08%) 
Oropharyngeal pain  1  2/13 (15.38%)  1/13 (7.69%) 
Dyspnoea  1  1/13 (7.69%)  1/13 (7.69%) 
Nasal congestion  1  1/13 (7.69%)  1/13 (7.69%) 
Epistaxis  1  0/13 (0.00%)  1/13 (7.69%) 
Haemoptysis  1  1/13 (7.69%)  0/13 (0.00%) 
Lung infiltration  1  0/13 (0.00%)  1/13 (7.69%) 
Paranasal sinus discomfort  1  0/13 (0.00%)  1/13 (7.69%) 
Productive cough  1  0/13 (0.00%)  1/13 (7.69%) 
Rhinorrhoe  1  0/13 (0.00%)  1/13 (7.69%) 
Throat irritation  1  1/13 (7.69%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  8/13 (61.54%)  7/13 (53.85%) 
Rash  1  1/13 (7.69%)  2/13 (15.38%) 
Erythema  1  1/13 (7.69%)  1/13 (7.69%) 
Pruritus  1  1/13 (7.69%)  1/13 (7.69%) 
Pruritus generalised  1  2/13 (15.38%)  0/13 (0.00%) 
Rash maculo-papular  1  1/13 (7.69%)  1/13 (7.69%) 
Blister  1  0/13 (0.00%)  1/13 (7.69%) 
Dry skin  1  0/13 (0.00%)  1/13 (7.69%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/13 (7.69%)  0/13 (0.00%) 
Pigmentation disorder  1  0/13 (0.00%)  1/13 (7.69%) 
Rash erythematous  1  0/13 (0.00%)  1/13 (7.69%) 
Rash maculovesicular  1  0/13 (0.00%)  1/13 (7.69%) 
Rash pruritic  1  0/13 (0.00%)  1/13 (7.69%) 
Skin hyperpigmentation  1  0/13 (0.00%)  1/13 (7.69%) 
Skin irritation  1  1/13 (7.69%)  0/13 (0.00%) 
Skin lesion  1  1/13 (7.69%)  0/13 (0.00%) 
Vascular disorders     
Hypertension  1  0/13 (0.00%)  1/13 (7.69%) 
Hypotension  1  0/13 (0.00%)  1/13 (7.69%) 
1
Term from vocabulary, MedDRA version 19.0
Indicates events were collected by systematic assessment
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: NCT01898078     History of Changes
Other Study ID Numbers: C14017
First Submitted: July 1, 2013
First Posted: July 12, 2013
Results First Submitted: February 21, 2018
Results First Posted: June 21, 2019
Last Update Posted: June 21, 2019