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An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy

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ClinicalTrials.gov Identifier: NCT01585987
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : November 18, 2015
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
Interventions Biological: Ipilimumab
Other: Best Supportive care (BSC)
Enrollment 143
Recruitment Details Acceptable first-line chemotherapy before randomization to this study for a participant was a regimen containing a fluoropyrimidine agent and a platinum salt. Study initiated July 2012. Primary endpoint July 2014. Study completed April 2015.
Pre-assignment Details 114 enrolled and randomized. 29 enrolled but not randomized to treatment group: 26 no longer met study criteria; 2 withdrew consent, 1 other.
Arm/Group Title Ipilimumab All Best Supportive Care (BSC)
Hide Arm/Group Description Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met. All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
Period Title: Randomized
Started 57 57
Completed 57 51
Not Completed 0 6
Reason Not Completed
Withdrawal by Subject             0             4
No longer met criteria             0             2
Period Title: Treated
Started 57 51
Completed 3 2
Not Completed 54 49
Reason Not Completed
Disease Progression             39             36
Study Drug Toxicity             9             5
Adverse Event             3             0
Withdrawal by Subject             1             2
Death             1             0
Lost to Follow-up             0             1
Maximum Clinical Benefit             0             1
Non-Specified             1             2
Subject Request             0             1
Poor/Non-Compliance             0             1
Arm/Group Title Ipilimumab All Best Supportive Care (BSC) Total
Hide Arm/Group Description Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met. BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. Total of all reporting groups
Overall Number of Baseline Participants 57 57 114
Hide Baseline Analysis Population Description
All participants randomized to a treatment arm are summarized.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 114 participants
65.0
(34 to 86)
62.0
(32 to 80)
64.0
(32 to 86)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Less than (<) 65 years of age 28 35 63
Greater, equal to (>=) 65 years of age 29 22 51
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Female
21
  36.8%
16
  28.1%
37
  32.5%
Male
36
  63.2%
41
  71.9%
77
  67.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Russian Federation 1 1 2
Singapore 1 1 2
Hong Kong 1 0 1
United States 8 6 14
Japan 7 5 12
Taiwan 1 0 1
Poland 0 2 2
Korea, Republic of 21 24 45
Italy 11 8 19
France 3 5 8
Germany 1 0 1
Spain 2 5 7
1.Primary Outcome
Title Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
Hide Description irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.
Time Frame Randomization up to 91 irPFS events (Approximately 19 months )
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who were randomized were summarized.
Arm/Group Title Ipilimumab All Best Supportive Care (BSC)
Hide Arm/Group Description:
Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
Overall Number of Participants Analyzed 57 57
Median (95% Confidence Interval)
Unit of Measure: Months
2.9240
(1.6100 to 5.1580)
4.8950
(3.4500 to 6.5380)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab, All Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0972
Comments Significance level used: 0.2
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.439
Confidence Interval (2-Sided) 80%
1.085 to 1.908
Estimation Comments The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model
2.Secondary Outcome
Title Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
Hide Description PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).
Time Frame Randomization up to 91 irPFS events (Approximately 19 months )
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to a treatment group were summarized.
Arm/Group Title Ipilimumab All Best Supportive Care (BSC)
Hide Arm/Group Description:
Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
Overall Number of Participants Analyzed 57 57
Median (95% Confidence Interval)
Unit of Measure: Months
2.7270
(1.4460 to 2.9570)
4.8950
(3.4500 to 6.0780)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab, All Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0336
Comments Significance level used: 0.2
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.588
Confidence Interval (2-Sided) 80%
1.199 to 2.103
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS) at Primary Endpoint
Hide Description OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Time Frame Randomization up to 91 irPFS events (Approximately 19 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to a treatment group and who received at least one dose of active drug were summarized.
Arm/Group Title Ipilimumab All Best Supportive Care (BSC)
Hide Arm/Group Description:
Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
Overall Number of Participants Analyzed 57 51
Median (95% Confidence Interval)
Unit of Measure: Months
16.7560
(11.7950 to 23.1290)
12.0570 [1] 
(9.3310 to NA)
[1]
Not estimable since the largest observation was censored.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab, All Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6433
Comments Significance level used: 0.2
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.874
Confidence Interval (2-Sided) 80%
0.602 to 1.269
Estimation Comments HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.
4.Secondary Outcome
Title Overall Survival (OS) at Study Completion
Hide Description OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Time Frame Randomization up to end of study, April 2015 (Approximately 28 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to a treatment group and who received at least one dose of active drug were summarized.
Arm/Group Title Ipilimumab All Best Supportive Care (BSC)
Hide Arm/Group Description:
Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
Overall Number of Participants Analyzed 57 57
Median (95% Confidence Interval)
Unit of Measure: Months
12.68
(10.51 to 18.92)
12.06 [1] 
(9.33 to NA)
[1]
Upper limit was not estimable.
5.Secondary Outcome
Title Percentage of Participants With Immune-Related Best Overall Response (irBOR)
Hide Description IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).
Time Frame Randomization up to 91 irPFS events (Approximately 19 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to a treatment group were summarized.
Arm/Group Title Ipilimumab All Best Supportive Care (BSC)
Hide Arm/Group Description:
Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of participants
1.8 7.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ipilimumab, All Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3686
Comments Significance level used: 0.2
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.0549
Confidence Interval (2-Sided) 80%
0.7009 to 47.6447
Estimation Comments [Not Specified]
Time Frame Randomization to end of study (April 2015)
Adverse Event Reporting Description Study initiated: July 2012; End of Study: April 2015
 
Arm/Group Title Ipilimumab Active Best Supportive Care (BSC) Non-Active BSC
Hide Arm/Group Description Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization) Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug)
All-Cause Mortality
Ipilimumab Active Best Supportive Care (BSC) Non-Active BSC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ipilimumab Active Best Supportive Care (BSC) Non-Active BSC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/57 (54.39%)   19/45 (42.22%)   1/6 (16.67%) 
Blood and lymphatic system disorders       
Anaemia  1  3/57 (5.26%)  2/45 (4.44%)  0/6 (0.00%) 
Febrile neutropenia  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Cardiac disorders       
Acute coronary syndrome  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Cardio-respiratory arrest  1  1/57 (1.75%)  1/45 (2.22%)  0/6 (0.00%) 
Endocrine disorders       
Hypopituitarism  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Hypothyroidism  1  2/57 (3.51%)  0/45 (0.00%)  0/6 (0.00%) 
Endocrine disorder  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/57 (1.75%)  4/45 (8.89%)  0/6 (0.00%) 
Dysphagia  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Intestinal obstruction  1  1/57 (1.75%)  1/45 (2.22%)  0/6 (0.00%) 
Large intestinal obstruction  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Obstruction gastric  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Colitis ischaemic  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Dyspepsia  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Vomiting  1  2/57 (3.51%)  0/45 (0.00%)  0/6 (0.00%) 
Colitis  1  3/57 (5.26%)  0/45 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  7/57 (12.28%)  0/45 (0.00%)  0/6 (0.00%) 
Gastrointestinal haemorrhage  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
General disorders       
Pyrexia  1  1/57 (1.75%)  0/45 (0.00%)  1/6 (16.67%) 
Hypothermia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Performance status decreased  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Death  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Disease progression  1  6/57 (10.53%)  4/45 (8.89%)  0/6 (0.00%) 
General physical health deterioration  1  1/57 (1.75%)  1/45 (2.22%)  0/6 (0.00%) 
Malaise  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Asthenia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Chest pain  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Fatigue  1  3/57 (5.26%)  1/45 (2.22%)  0/6 (0.00%) 
Hepatobiliary disorders       
Cholecystocholangitis  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Hyperbilirubinaemia  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Hepatitis acute  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Infections and infestations       
Pneumocystis jirovecii pneumonia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Peritonitis  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Urinary tract infection  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Device related infection  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Escherichia sepsis  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Pneumonia  1  4/57 (7.02%)  1/45 (2.22%)  0/6 (0.00%) 
Abdominal infection  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Compression fracture  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Investigations       
Transaminases increased  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  7/57 (12.28%)  0/45 (0.00%)  0/6 (0.00%) 
Hypoglycaemia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Dehydration  1  2/57 (3.51%)  0/45 (0.00%)  0/6 (0.00%) 
Hypokalaemia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Failure to thrive  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Hyponatraemia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Hyperglycaemia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Back pain  1  2/57 (3.51%)  0/45 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung neoplasm malignant  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Metastatic gastric cancer  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Malignant neoplasm progression  1  0/57 (0.00%)  2/45 (4.44%)  0/6 (0.00%) 
Gastrointestinal cancer metastatic  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Neoplasm malignant  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Nervous system disorders       
Dizziness  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Peripheral sensory neuropathy  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Syncope  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Cerebrovascular accident  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Psychiatric disorders       
Delirium  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Haematuria  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/57 (0.00%)  1/45 (2.22%)  0/6 (0.00%) 
Pneumonia aspiration  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Pleural effusion  1  0/57 (0.00%)  2/45 (4.44%)  0/6 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/57 (1.75%)  0/45 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ipilimumab Active Best Supportive Care (BSC) Non-Active BSC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/57 (96.49%)   42/45 (93.33%)   4/6 (66.67%) 
Blood and lymphatic system disorders       
Neutropenia  1  2/57 (3.51%)  7/45 (15.56%)  0/6 (0.00%) 
Anaemia  1  12/57 (21.05%)  5/45 (11.11%)  0/6 (0.00%) 
Endocrine disorders       
Hypothyroidism  1  4/57 (7.02%)  0/45 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  12/57 (21.05%)  16/45 (35.56%)  0/6 (0.00%) 
Dysphagia  1  0/57 (0.00%)  1/45 (2.22%)  2/6 (33.33%) 
Abdominal pain upper  1  6/57 (10.53%)  4/45 (8.89%)  0/6 (0.00%) 
Constipation  1  10/57 (17.54%)  12/45 (26.67%)  0/6 (0.00%) 
Dyspepsia  1  5/57 (8.77%)  3/45 (6.67%)  0/6 (0.00%) 
Gastrooesophageal reflux disease  1  3/57 (5.26%)  0/45 (0.00%)  0/6 (0.00%) 
Nausea  1  19/57 (33.33%)  16/45 (35.56%)  0/6 (0.00%) 
Vomiting  1  17/57 (29.82%)  12/45 (26.67%)  0/6 (0.00%) 
Abdominal distension  1  3/57 (5.26%)  2/45 (4.44%)  0/6 (0.00%) 
Diarrhoea  1  19/57 (33.33%)  9/45 (20.00%)  0/6 (0.00%) 
General disorders       
Pyrexia  1  9/57 (15.79%)  7/45 (15.56%)  0/6 (0.00%) 
Pain  1  3/57 (5.26%)  0/45 (0.00%)  0/6 (0.00%) 
Influenza like illness  1  0/57 (0.00%)  3/45 (6.67%)  0/6 (0.00%) 
Asthenia  1  12/57 (21.05%)  7/45 (15.56%)  0/6 (0.00%) 
Chest pain  1  3/57 (5.26%)  1/45 (2.22%)  0/6 (0.00%) 
Chills  1  3/57 (5.26%)  1/45 (2.22%)  0/6 (0.00%) 
Oedema peripheral  1  8/57 (14.04%)  5/45 (11.11%)  0/6 (0.00%) 
Fatigue  1  26/57 (45.61%)  9/45 (20.00%)  0/6 (0.00%) 
Mucosal inflammation  1  0/57 (0.00%)  4/45 (8.89%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Laceration  1  1/57 (1.75%)  0/45 (0.00%)  1/6 (16.67%) 
Investigations       
Alanine aminotransferase increased  1  9/57 (15.79%)  1/45 (2.22%)  0/6 (0.00%) 
Aspartate aminotransferase increased  1  9/57 (15.79%)  2/45 (4.44%)  0/6 (0.00%) 
Weight decreased  1  11/57 (19.30%)  5/45 (11.11%)  0/6 (0.00%) 
Haemoglobin decreased  1  3/57 (5.26%)  1/45 (2.22%)  0/6 (0.00%) 
Weight increased  1  3/57 (5.26%)  1/45 (2.22%)  1/6 (16.67%) 
Metabolism and nutrition disorders       
Decreased appetite  1  21/57 (36.84%)  14/45 (31.11%)  0/6 (0.00%) 
Hypokalaemia  1  8/57 (14.04%)  2/45 (4.44%)  0/6 (0.00%) 
Hyponatraemia  1  3/57 (5.26%)  1/45 (2.22%)  0/6 (0.00%) 
Hypoalbuminaemia  1  5/57 (8.77%)  5/45 (11.11%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  4/57 (7.02%)  1/45 (2.22%)  0/6 (0.00%) 
Arthralgia  1  3/57 (5.26%)  4/45 (8.89%)  0/6 (0.00%) 
Back pain  1  6/57 (10.53%)  3/45 (6.67%)  0/6 (0.00%) 
Bone pain  1  0/57 (0.00%)  0/45 (0.00%)  1/6 (16.67%) 
Pain in extremity  1  2/57 (3.51%)  2/45 (4.44%)  1/6 (16.67%) 
Neck pain  1  2/57 (3.51%)  0/45 (0.00%)  1/6 (16.67%) 
Nervous system disorders       
Dizziness  1  5/57 (8.77%)  2/45 (4.44%)  0/6 (0.00%) 
Peripheral sensory neuropathy  1  6/57 (10.53%)  1/45 (2.22%)  1/6 (16.67%) 
Headache  1  4/57 (7.02%)  1/45 (2.22%)  0/6 (0.00%) 
Neuropathy peripheral  1  10/57 (17.54%)  7/45 (15.56%)  0/6 (0.00%) 
Psychiatric disorders       
Anxiety  1  0/57 (0.00%)  4/45 (8.89%)  0/6 (0.00%) 
Insomnia  1  5/57 (8.77%)  6/45 (13.33%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Hiccups  1  1/57 (1.75%)  4/45 (8.89%)  0/6 (0.00%) 
Productive cough  1  3/57 (5.26%)  2/45 (4.44%)  0/6 (0.00%) 
Dyspnoea  1  6/57 (10.53%)  5/45 (11.11%)  0/6 (0.00%) 
Upper respiratory tract inflammation  1  0/57 (0.00%)  0/45 (0.00%)  1/6 (16.67%) 
Cough  1  5/57 (8.77%)  6/45 (13.33%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin ulcer  1  0/57 (0.00%)  0/45 (0.00%)  1/6 (16.67%) 
Palmar-plantar erythrodysaesthesia syndrome  1  4/57 (7.02%)  8/45 (17.78%)  0/6 (0.00%) 
Pruritus  1  25/57 (43.86%)  3/45 (6.67%)  0/6 (0.00%) 
Rash  1  15/57 (26.32%)  2/45 (4.44%)  1/6 (16.67%) 
Dry skin  1  3/57 (5.26%)  2/45 (4.44%)  0/6 (0.00%) 
Alopecia  1  3/57 (5.26%)  2/45 (4.44%)  0/6 (0.00%) 
Vascular disorders       
Hypertension  1  2/57 (3.51%)  2/45 (4.44%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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: NCT01585987     History of Changes
Other Study ID Numbers: CA184-162
2011-000853-22 ( EudraCT Number )
First Submitted: April 25, 2012
First Posted: April 26, 2012
Results First Submitted: July 15, 2015
Results First Posted: November 18, 2015
Last Update Posted: May 17, 2016