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Japanese Study of Ipilimumab Administered in Combination With Paclitaxel/Carboplatin in Patients With Nonsmall-cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01165216
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : July 22, 2014
Last Update Posted : July 22, 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 Non-Small Cell Lung Cancer
Interventions Drug: Ipilimumab, 3 mg
Drug: Ipilimumab, 10 mg
Drug: Paclitaxel
Drug: Carboplatin
Enrollment 15

Recruitment Details  
Pre-assignment Details Participants were enrolled in successive cohorts of 3 to 6 patients, using a standard 3+3 design. Of 15 patients enrolled, all received some treatment (chemotherapy or ipilimumab); 12 received at least 1 dose of ipilimumab.
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses). Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Period Title: Overall Study
Started 8 [1] 7 [1]
Received at Least 1 Dose of Ipilimumab 6 6
Completed 0 [2] 0 [2]
Not Completed 8 7
Reason Not Completed
Adverse Event             6             3
Withdrawal by Subject             1             1
Disease progression             1             3
[1]
Participants who received any study drug
[2]
Completed=still on study drug
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin Total
Hide Arm/Group Description Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses). Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses). Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
56.0  (12.62) 58.9  (10.25) 57.3  (11.26)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Younger than 65 years 7 4 11
65 years and older 1 3 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
2
  25.0%
1
  14.3%
3
  20.0%
Male
6
  75.0%
6
  85.7%
12
  80.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Japanese 8 7 15
Not reported 0 0 0
1.Primary Outcome
Title Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
Hide Description A DLT was defined as study drug-related adverse event occurring during the first 2 cycles after ipilimumab administration in the induction phase and was any of the following: Grade 4 absolute neutrophil count (ANC) decreased (<500 cells/ mm^3) for 7 or more consecutive days; febrile Neutropenia (body temperature ≥38.5° C with ANC <1000 /mm^3) lasting >3 days; Grade 4 platelet count decreased (<25,000 cells/mm^3) or Grade 3 platelet count decreased requiring a platelet transfusion; Grade 3 or greater nausea, vomiting, diarrhea, despite the use of adequate/maximal medical intervention; Grade 3 or greater aspartate transaminase/alanine transaminase level and rash that has not resolved to Grade 2 or lower within 2 weeks after onset; or any Grade 3 or greater nonhematologic toxicity (except Grade 3 fatigue, Grade 3 asthenia, Grade 3 transient arthralgia/myalgia, or Grade 3 transient abnormal electrolyte levels).
Time Frame Day 1 of Cycles 1 and 2 From Day 1 of Cycle 3 to Day 21 of Cycle 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ipilimumab
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Participants
2 1
2.Secondary Outcome
Title Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs Leading to Discontinuation
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. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. AE incidence was assessed from Day 1 until Week 24 and every 12 weeks thereafter during the maintenance period, until discontinuation of study drug, due to progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure, and at least every 4 weeks(±1 week) until all study drug-related toxicities had recovered to resolved, stabilized or returned to baseline or were deemed irreversible during the follow-up period).
Time Frame Continuously from Day 1 to Week 24 and every12 weeks thereafter during maintenance until discontinuation of drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of any study drug
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 8 7
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0
SAEs 3 1
Drug-related SAEs 3 1
Drug-related AEs 8 7
AEs leading to discontinuation 6 3
Drug-related AEs leading to discontinuation 6 3
3.Secondary Outcome
Title Number of Participants With Best Overall Response (BOR) of Partial Response (PR) or Stable Disease
Hide Description Tumor response was determined for all participants with measurable lesions by radiologic responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The BOR was the best response recorded from start of treatment until disease progression/recurrence. RECIST for target lesions: PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started. At minimum, tumor measurements were to be obtained at screening, every 6 weeks (±1 week) during the induction phase and every 12 weeks (±1 week) during the maintenance phase.
Time Frame Day 1 of Cycle 3, Day 1 of Cycle 5, and Day 22 of Cycle 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study drug
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 8 7
Measure Type: Number
Unit of Measure: Participants
PR 3 3
Stable disease 3 4
4.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Ipilimumab
Hide Description Cmax was recorded directly from experimental observations. Actual times were used for the analyses. Cmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.
Time Frame During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ipilimumab
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
72.8
(12%)
201
(21%)
5.Secondary Outcome
Title Trough Observed Serum Concentration (Cmin) of Ipilimumab
Hide Description Cmin was recorded directly from experimental observations. Actual times were used for the analyses. Cmin measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 (Day 8), and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.
Time Frame During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ipilimumab
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: ug/mL
Day 22 11.06  (1.007) 26.65  (4.599)
Day 43 (n=3, 5) 10.98  (4.773) 26.68  (14.247)
Day 64 (n=3, 3) 13.90  (2.600) 26.40  (7.904)
6.Secondary Outcome
Title Area Under the Concentration Curve From Time 0 to Day 21 (in 1 Interval Dosing) (AUC[0-21d]) for Ipilimumab
Hide Description The AUC(0-21d) was calculated using a mixture of log- and linear-trapezoidal summations. Using no weighting factor, the terminal log-liner phase of the concentration-time curve was determined by least-square linear regression of at least 3 data points. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods using a validated PK analysis program. Actual times were used for the analyses. AUC(0-21d) measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.
Time Frame During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ipilimumab
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug*h/mL
12632
(12%)
36489
(21%)
7.Secondary Outcome
Title Time of Maximum Observed Serum Concentration (Tmax)
Hide Description Tmax was recorded directly from experimental observations. Actual times were used for the analyses. Tmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.
Time Frame During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ipilimumab
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 6 6
Median (Full Range)
Unit of Measure: Hours
2.75
(1.37 to 4.08)
3.98
(1.45 to 23.8)
8.Secondary Outcome
Title Serum Half-life (T-HALF) of Ipilimumab
Hide Description T-HALF was calculated as the ratio of ln(2) to elimination rate constant (K), where K was estimated as negative slope obtained by regression of the terminal log-linear portion of the serum concentration vs time profile following the ipilimumab dose on Day 1 of Cycle 3. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods, using a validated PK analysis program. Actual times were used for the analyses. T-HALF measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.
Time Frame During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ipilimumab
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description:
Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30 -60 minutes every 3 weeks (up to 6 doses).
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Days
13.3  (3.64) 11.3  (2.83)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Hide Arm/Group Description Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses). Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
All-Cause Mortality
Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   1/7 (14.29%) 
Endocrine disorders     
Hypoparathyroidism  1  1/8 (12.50%)  0/7 (0.00%) 
Adrenal insufficiency  1  1/8 (12.50%)  0/7 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  1/8 (12.50%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea exertional  1  1/8 (12.50%)  0/7 (0.00%) 
Pneumonitis  1  0/8 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  7/8 (87.50%)  7/7 (100.00%) 
Febrile neutropenia  1  1/8 (12.50%)  0/7 (0.00%) 
Lymphadenopathy  1  1/8 (12.50%)  0/7 (0.00%) 
Thrombocytopenia  1  1/8 (12.50%)  2/7 (28.57%) 
Lymphopenia  1  2/8 (25.00%)  0/7 (0.00%) 
Anaemia  1  0/8 (0.00%)  1/7 (14.29%) 
Leukopenia  1  4/8 (50.00%)  2/7 (28.57%) 
Cardiac disorders     
Tachycardia  1  0/8 (0.00%)  1/7 (14.29%) 
Supraventricular extrasystoles  1  0/8 (0.00%)  1/7 (14.29%) 
Palpitations  1  1/8 (12.50%)  0/7 (0.00%) 
Ear and labyrinth disorders     
Tinnitus  1  0/8 (0.00%)  1/7 (14.29%) 
Endocrine disorders     
Cushingoid  1  0/8 (0.00%)  1/7 (14.29%) 
Inappropriate antidiuretic hormone secretion  1  1/8 (12.50%)  0/7 (0.00%) 
Adrenal insufficiency  1  1/8 (12.50%)  0/7 (0.00%) 
Eye disorders     
Eye inflammation  1  1/8 (12.50%)  0/7 (0.00%) 
Vitreous floaters  1  1/8 (12.50%)  0/7 (0.00%) 
Conjunctivitis  1  1/8 (12.50%)  0/7 (0.00%) 
Eyelid oedema  1  1/8 (12.50%)  1/7 (14.29%) 
Retinal haemorrhage  1  1/8 (12.50%)  0/7 (0.00%) 
Gastrointestinal disorders     
Cheilitis  1  0/8 (0.00%)  1/7 (14.29%) 
Stomatitis  1  2/8 (25.00%)  1/7 (14.29%) 
Nausea  1  5/8 (62.50%)  4/7 (57.14%) 
Gastritis  1  1/8 (12.50%)  0/7 (0.00%) 
Dental caries  1  1/8 (12.50%)  0/7 (0.00%) 
Tongue coated  1  1/8 (12.50%)  0/7 (0.00%) 
Abdominal discomfort  1  0/8 (0.00%)  1/7 (14.29%) 
Constipation  1  4/8 (50.00%)  5/7 (71.43%) 
Diarrhoea  1  3/8 (37.50%)  2/7 (28.57%) 
Diverticulum  1  0/8 (0.00%)  1/7 (14.29%) 
Duodenitis  1  0/8 (0.00%)  1/7 (14.29%) 
Enterocolitis  1  0/8 (0.00%)  1/7 (14.29%) 
Gastric disorder  1  0/8 (0.00%)  1/7 (14.29%) 
Gastrooesophageal reflux disease  1  0/8 (0.00%)  1/7 (14.29%) 
Vomiting  1  1/8 (12.50%)  2/7 (28.57%) 
General disorders     
Injection site erythema  1  1/8 (12.50%)  0/7 (0.00%) 
Hypothermia  1  1/8 (12.50%)  0/7 (0.00%) 
Injection site pain  1  2/8 (25.00%)  0/7 (0.00%) 
Pyrexia  1  3/8 (37.50%)  3/7 (42.86%) 
Fatigue  1  2/8 (25.00%)  5/7 (71.43%) 
Immune system disorders     
Seasonal allergy  1  1/8 (12.50%)  0/7 (0.00%) 
Infections and infestations     
Tinea pedis  1  1/8 (12.50%)  0/7 (0.00%) 
Bronchitis  1  0/8 (0.00%)  1/7 (14.29%) 
Upper respiratory tract infection  1  0/8 (0.00%)  1/7 (14.29%) 
Nasopharyngitis  1  0/8 (0.00%)  1/7 (14.29%) 
Urinary tract infection  1  1/8 (12.50%)  0/7 (0.00%) 
Cystitis  1  1/8 (12.50%)  0/7 (0.00%) 
Injury, poisoning and procedural complications     
Infusion related reaction  1  0/8 (0.00%)  1/7 (14.29%) 
Investigations     
Blood bilirubin increased  1  0/8 (0.00%)  1/7 (14.29%) 
Gamma-glutamyltransferase increased  1  0/8 (0.00%)  1/7 (14.29%) 
Haemoglobin decreased  1  0/8 (0.00%)  4/7 (57.14%) 
Blood corticotrophin decreased  1  0/8 (0.00%)  1/7 (14.29%) 
Weight decreased  1  4/8 (50.00%)  3/7 (42.86%) 
Weight increased  1  0/8 (0.00%)  1/7 (14.29%) 
Blood pressure decreased  1  0/8 (0.00%)  1/7 (14.29%) 
Blood sodium decreased  1  0/8 (0.00%)  1/7 (14.29%) 
Blood magnesium decreased  1  0/8 (0.00%)  1/7 (14.29%) 
Blood cortisol decreased  1  0/8 (0.00%)  1/7 (14.29%) 
Amylase increased  1  2/8 (25.00%)  2/7 (28.57%) 
Blood thyroid stimulating hormone decreased  1  0/8 (0.00%)  1/7 (14.29%) 
C-reactive protein increased  1  2/8 (25.00%)  1/7 (14.29%) 
Electrocardiogram QT prolonged  1  4/8 (50.00%)  2/7 (28.57%) 
Lipase increased  1  0/8 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  1/8 (12.50%)  1/7 (14.29%) 
Hypocalcaemia  1  1/8 (12.50%)  0/7 (0.00%) 
Hypomagnesaemia  1  1/8 (12.50%)  0/7 (0.00%) 
Hypokalaemia  1  0/8 (0.00%)  1/7 (14.29%) 
Hypophosphataemia  1  0/8 (0.00%)  1/7 (14.29%) 
Dehydration  1  0/8 (0.00%)  1/7 (14.29%) 
Hypoglycaemia  1  0/8 (0.00%)  1/7 (14.29%) 
Decreased appetite  1  7/8 (87.50%)  6/7 (85.71%) 
Hyperglycaemia  1  1/8 (12.50%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  5/8 (62.50%)  2/7 (28.57%) 
Pain in extremity  1  1/8 (12.50%)  0/7 (0.00%) 
Arthralgia  1  8/8 (100.00%)  6/7 (85.71%) 
Back pain  1  1/8 (12.50%)  0/7 (0.00%) 
Nervous system disorders     
Headache  1  1/8 (12.50%)  0/7 (0.00%) 
Dysgeusia  1  2/8 (25.00%)  1/7 (14.29%) 
Peripheral motor neuropathy  1  1/8 (12.50%)  0/7 (0.00%) 
Dizziness postural  1  1/8 (12.50%)  0/7 (0.00%) 
Peripheral sensory neuropathy  1  7/8 (87.50%)  6/7 (85.71%) 
Somnolence  1  1/8 (12.50%)  0/7 (0.00%) 
Hypoaesthesia  1  3/8 (37.50%)  0/7 (0.00%) 
Psychiatric disorders     
Insomnia  1  2/8 (25.00%)  2/7 (28.57%) 
Renal and urinary disorders     
Haematuria  1  1/8 (12.50%)  0/7 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia  1  1/8 (12.50%)  0/7 (0.00%) 
Menorrhagia  1  1/8 (12.50%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/8 (25.00%)  0/7 (0.00%) 
Hiccups  1  0/8 (0.00%)  2/7 (28.57%) 
Oropharyngeal pain  1  2/8 (25.00%)  2/7 (28.57%) 
Epistaxis  1  0/8 (0.00%)  2/7 (28.57%) 
Respiratory tract haemorrhage  1  1/8 (12.50%)  0/7 (0.00%) 
Dyspnoea exertional  1  1/8 (12.50%)  0/7 (0.00%) 
Cough  1  1/8 (12.50%)  0/7 (0.00%) 
Pneumonitis  1  0/8 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  2/8 (25.00%)  2/7 (28.57%) 
Haemorrhage subcutaneous  1  1/8 (12.50%)  0/7 (0.00%) 
Alopecia  1  6/8 (75.00%)  7/7 (100.00%) 
Pruritus  1  1/8 (12.50%)  4/7 (57.14%) 
Rash maculo-papular  1  0/8 (0.00%)  2/7 (28.57%) 
Dermatitis acneiform  1  0/8 (0.00%)  2/7 (28.57%) 
Rash  1  6/8 (75.00%)  5/7 (71.43%) 
Pigmentation disorder  1  1/8 (12.50%)  0/7 (0.00%) 
Vascular disorders     
Flushing  1  0/8 (0.00%)  1/7 (14.29%) 
Hypertension  1  0/8 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
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
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01165216     History of Changes
Other Study ID Numbers: CA184-113
First Submitted: July 16, 2010
First Posted: July 19, 2010
Results First Submitted: June 23, 2014
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014