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A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer (BRIGHTER)

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: NCT02178956
Recruitment Status : Completed
First Posted : July 1, 2014
Results First Posted : May 10, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Oncology, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Gastric Cancer
Gastroesophageal Junction Cancer
Interventions Drug: BBI608
Drug: Paclitaxel
Other: Placebo
Enrollment 714
Recruitment Details 714 patients were enrolled to this study from 02OCT2014 to 20SEP2017 across 204 sites in 22 countries.
Pre-assignment Details Study arm was determined at patient randomization to the study, no pre-assignment activities occurred.
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
Period Title: Overall Study
Started 357 357
Completed 286 279
Not Completed 71 78
Reason Not Completed
Lost to Follow-up             4             4
Sponsor terminated study             49             58
Withdrawal by Subject             15             11
Various Reasons             3             5
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel Total
Hide Arm/Group Description Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Total of all reporting groups
Overall Number of Baseline Participants 357 357 714
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 357 participants 357 participants 714 participants
60.787  (11.5130) 59.887  (11.1231) 60.337  (11.3207)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 357 participants 357 participants 714 participants
Female
96
  26.9%
103
  28.9%
199
  27.9%
Male
261
  73.1%
254
  71.1%
515
  72.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 357 participants 357 participants 714 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.1%
Asian
107
  30.0%
102
  28.6%
209
  29.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   0.6%
3
   0.8%
5
   0.7%
White
237
  66.4%
240
  67.2%
477
  66.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   3.1%
11
   3.1%
22
   3.1%
ECOG   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 357 participants 357 participants 714 participants
0: Fully active, able to carry on all pre-disease performance without restriction
128
  35.9%
134
  37.5%
262
  36.7%
1: Restricted in physically strenuous activity but ambulatory, can carry out light/sedentary work
229
  64.1%
223
  62.5%
452
  63.3%
[1]
Measure Description: The ECOG Performance Status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The higher the score, the more restricted the patient is clinically determined to be.
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 357 participants 357 participants 714 participants
23.24  (4.481) 23.56  (4.709) 23.40  (4.596)
1.Primary Outcome
Title Overall Survival
Hide Description The primary objective of this study is to assess the effect of orally administered BBI608 plus weekly paclitaxel, in comparison to placebo plus weekly paclitaxel on the Overall Survival of patients with advanced histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma who failed treatment with one platinum/fluoropyrimidine containing regimen for unresectable or metastatic disease.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description:
Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
Overall Number of Participants Analyzed 357 357
Median (95% Confidence Interval)
Unit of Measure: Months
6.93
(6.28 to 7.69)
7.36
(6.64 to 8.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin + Paclitaxel, Placebo + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8596
Comments two-sided
Method Log Rank
Comments stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.86 to 1.02
Estimation Comments HR is for napabucasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.
2.Secondary Outcome
Title Progression Free Survival
Hide Description Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause which comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in anon-target lesion, or the appearance of new lesions.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description:
Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
Overall Number of Participants Analyzed 357 357
Median (95% Confidence Interval)
Unit of Measure: Months
3.55
(3.22 to 3.68)
3.68
(3.48 to 3.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin + Paclitaxel, Placebo + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9028
Comments two sided
Method Log Rank
Comments stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.85 to 1.19
Estimation Comments HR is for napabucuasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.
3.Secondary Outcome
Title Objective Response Rate
Hide Description Objective Response Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description:
Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients were included in this group had a baseline scan and at least one assessment a minimum of 6 weeks from baseline.
Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients were included in this group had a baseline scan and at least one assessment a minimum of 6 weeks from baseline.
Overall Number of Participants Analyzed 289 283
Measure Type: Count of Participants
Unit of Measure: Participants
16
   5.5%
18
   6.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin + Paclitaxel, Placebo + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7359
Comments 2-sided
Method Cochran-Mantel-Haenszel
Comments Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.60 to 1.44
Estimation Comments Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.
4.Secondary Outcome
Title Disease Control Rate
Hide Description Disease control Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR+SD) based on RECIST 1.1.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description:
Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients were included in this group had a baseline scan and at least one assessment a minimum of 6 weeks from baseline.
Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients were included in this group had a baseline scan and at least one assessment a minimum of 6 weeks from baseline.
Overall Number of Participants Analyzed 289 283
Measure Type: Count of Participants
Unit of Measure: Participants
55
  19.0%
58
  20.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin + Paclitaxel, Placebo + Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6555
Comments 2-sided
Method Cochran-Mantel-Haenszel
Comments Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.66 to 1.30
Estimation Comments Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.
5.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description All patients who have received at least one dose of BBI608/Placebo will be included in the safety analysis. The number of patients who experienced at least one adverse event is reported.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description:
Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients included this group received at least one dose of study drug.
Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Patients included this group received at least one dose of study drug.
Overall Number of Participants Analyzed 357 350
Measure Type: Count of Participants
Unit of Measure: Participants
352
  98.6%
338
  96.6%
Time Frame Adverse Events were collected from the time the patient signed informed consent until 30 days after the last protocol treatment administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Napabucasin + Paclitaxel Placebo + Paclitaxel
Hide Arm/Group Description Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous [IV]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period.
All-Cause Mortality
Napabucasin + Paclitaxel Placebo + Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   286/357 (80.11%)   275/350 (78.57%) 
Hide Serious Adverse Events
Napabucasin + Paclitaxel Placebo + Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   125/357 (35.01%)   101/350 (28.86%) 
Blood and lymphatic system disorders     
Anaemia   6/357 (1.68%)  5/350 (1.43%) 
Agranulocytosis   0/357 (0.00%)  1/350 (0.29%) 
Febrile neutropenia   1/357 (0.28%)  2/350 (0.57%) 
Bone marrow   2/357 (0.56%)  0/350 (0.00%) 
Microangiopathic haemolytic anaemia   0/357 (0.00%)  1/350 (0.29%) 
Neutropenia   0/357 (0.00%)  1/350 (0.29%) 
Cardiac disorders     
Acute myocardial infarction   1/357 (0.28%)  0/350 (0.00%) 
Angina unstable   1/357 (0.28%)  0/350 (0.00%) 
Atrial fibrillation   4/357 (1.12%)  1/350 (0.29%) 
Myocardial infarction   0/357 (0.00%)  1/350 (0.29%) 
Bradycardia   1/357 (0.28%)  0/350 (0.00%) 
Palpitations   1/357 (0.28%)  0/350 (0.00%) 
Gastrointestinal disorders     
Vomiting   14/357 (3.92%)  2/350 (0.57%) 
Nausea   6/357 (1.68%)  0/350 (0.00%) 
Abdominal Pain   8/357 (2.24%)  5/350 (1.43%) 
Diarrhoea   10/357 (2.80%)  3/350 (0.86%) 
Abdominal pain upper   4/357 (1.12%)  1/350 (0.29%) 
Gastric haemorrhage   4/357 (1.12%)  3/350 (0.86%) 
Intestinal obstruction   5/357 (1.40%)  3/350 (0.86%) 
Ascites   3/357 (0.84%)  3/350 (0.86%) 
Dysphagia   3/357 (0.84%)  5/350 (1.43%) 
Upper gastrointestinal haemorrhage   3/357 (0.84%)  2/350 (0.57%) 
Abdominal distension   2/357 (0.56%)  1/350 (0.29%) 
Colitis   2/357 (0.56%)  0/350 (0.00%) 
Gastritis   2/357 (0.56%)  0/350 (0.00%) 
Gastrointestinal haemorrhage   2/357 (0.56%)  1/350 (0.29%) 
Ileus   2/357 (0.56%)  3/350 (0.86%) 
Small intestinal obstruction   2/357 (0.56%)  4/350 (1.14%) 
Abdominal pain lower   1/357 (0.28%)  0/350 (0.00%) 
Gastric perforation   1/357 (0.28%)  0/350 (0.00%) 
Gastric stenosis   1/357 (0.28%)  1/350 (0.29%) 
Gastrooesophageal reflux disease   1/357 (0.28%)  0/350 (0.00%) 
Haematemesis   1/357 (0.28%)  3/350 (0.86%) 
Intra-abdominal haemorrhage   1/357 (0.28%)  0/350 (0.00%) 
Jejunal stenosis   1/357 (0.28%)  0/350 (0.00%) 
Large intestine obstruction   1/357 (0.28%)  0/350 (0.00%) 
Large intestine perforation   1/357 (0.28%)  0/350 (0.00%) 
Mechanical ileus   1/357 (0.28%)  0/350 (0.00%) 
Oesophageal haemorrhage   1/357 (0.28%)  0/350 (0.00%) 
Oesophagitis   1/357 (0.28%)  0/350 (0.00%) 
Constipation   0/357 (0.00%)  1/350 (0.29%) 
Gastrointestinal obstruction   0/357 (0.00%)  1/350 (0.29%) 
Subileus   1/357 (0.28%)  0/350 (0.00%) 
Oesophageal obstruction   0/357 (0.00%)  1/350 (0.29%) 
General disorders     
Fatigue   5/357 (1.40%)  0/350 (0.00%) 
Pyrexia   6/357 (1.68%)  6/350 (1.71%) 
Adverse event   1/357 (0.28%)  0/350 (0.00%) 
General physical health deterioration   3/357 (0.84%)  1/350 (0.29%) 
Asthenia   4/357 (1.12%)  3/350 (0.86%) 
Death   0/357 (0.00%)  3/350 (0.86%) 
Hyperthermia   0/357 (0.00%)  1/350 (0.29%) 
Stent malfunction   0/357 (0.00%)  1/350 (0.29%) 
Hepatobiliary disorders     
Sudden death   1/357 (0.28%)  0/350 (0.00%) 
Bile duct obstruction   1/357 (0.28%)  1/350 (0.29%) 
Cholangitis   1/357 (0.28%)  1/350 (0.29%) 
Cholecystitis acute   1/357 (0.28%)  0/350 (0.00%) 
Hepatic failure   1/357 (0.28%)  0/350 (0.00%) 
Hypertransaminasaemia   0/357 (0.00%)  1/350 (0.29%) 
Immune system disorders     
Anaphylactic reaction   0/357 (0.00%)  1/350 (0.29%) 
Hypersensitivity   0/357 (0.00%)  1/350 (0.29%) 
Drug hypersensitivity   1/357 (0.28%)  0/350 (0.00%) 
Infections and infestations     
Pneumonia   5/357 (1.40%)  4/350 (1.14%) 
Respiratory tract infection   3/357 (0.84%)  0/350 (0.00%) 
Urinary tract infection   3/357 (0.84%)  2/350 (0.57%) 
Lung infection   4/357 (1.12%)  3/350 (0.86%) 
Peritonitis   2/357 (0.56%)  1/350 (0.29%) 
Sepsis   2/357 (0.56%)  1/350 (0.29%) 
Septic shock   2/357 (0.56%)  1/350 (0.29%) 
Abdominal infection   1/357 (0.28%)  1/350 (0.29%) 
Bronchitis   1/357 (0.28%)  0/350 (0.00%) 
Bronchopneumonia   1/357 (0.28%)  0/350 (0.00%) 
Clostridium difficile colitis   1/357 (0.28%)  0/350 (0.00%) 
Diverticulitis   1/357 (0.28%)  0/350 (0.00%) 
Gastrointestinal infection   1/357 (0.28%)  0/350 (0.00%) 
Infection   0/357 (0.00%)  2/350 (0.57%) 
Herpes zoster   1/357 (0.28%)  0/350 (0.00%) 
Pyonephrosis   1/357 (0.28%)  0/350 (0.00%) 
Localised infection   0/357 (0.00%)  1/350 (0.29%) 
Pharyngitis   0/357 (0.00%)  1/350 (0.29%) 
Upper respiratory tract infection   0/357 (0.00%)  2/350 (0.57%) 
Injury, poisoning and procedural complications     
Fall   0/357 (0.00%)  1/350 (0.29%) 
Femur fracture   1/357 (0.28%)  0/350 (0.00%) 
Investigations     
Neutrophil count decreased   2/357 (0.56%)  0/350 (0.00%) 
Blood creatinine increased   1/357 (0.28%)  0/350 (0.00%) 
General physical condition abnormal   1/357 (0.28%)  0/350 (0.00%) 
White blood cell count decreased   1/357 (0.28%)  1/350 (0.29%) 
Alanine aminotransferase increased   0/357 (0.00%)  1/350 (0.29%) 
Aspartate aminotransferase increased   0/357 (0.00%)  1/350 (0.29%) 
Blood bilirubin increased   0/357 (0.00%)  2/350 (0.57%) 
Blood creatine phosphokinase increased   0/357 (0.00%)  1/350 (0.29%) 
Blood urea increased   0/357 (0.00%)  1/350 (0.29%) 
Liver function test abnormal   0/357 (0.00%)  1/350 (0.29%) 
Platelet count decreased   0/357 (0.00%)  1/350 (0.29%) 
Transaminases increased   0/357 (0.00%)  1/350 (0.29%) 
Metabolism and nutrition disorders     
Decreased appetite   5/357 (1.40%)  2/350 (0.57%) 
Fluid retention   1/357 (0.28%)  0/350 (0.00%) 
Hypokalaemia   2/357 (0.56%)  0/350 (0.00%) 
Dehydration   5/357 (1.40%)  1/350 (0.29%) 
Hypoglycaemia   0/357 (0.00%)  1/350 (0.29%) 
Hyponatraemia   0/357 (0.00%)  2/350 (0.57%) 
Musculoskeletal and connective tissue disorders     
Bone pain   0/357 (0.00%)  1/350 (0.29%) 
Muscular weakness   1/357 (0.28%)  0/350 (0.00%) 
Back pain   2/357 (0.56%)  3/350 (0.86%) 
Flank pain   0/357 (0.00%)  1/350 (0.29%) 
Spinal osteoarthritis   0/357 (0.00%)  1/350 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer   0/357 (0.00%)  1/350 (0.29%) 
Metastases to meninges   0/357 (0.00%)  1/350 (0.29%) 
Tumour haemorrhage   0/357 (0.00%)  1/350 (0.29%) 
Tumour pain   0/357 (0.00%)  1/350 (0.29%) 
Nervous system disorders     
Cerebral infarction   1/357 (0.28%)  0/350 (0.00%) 
Cerebrovascular accident   3/357 (0.84%)  0/350 (0.00%) 
Brain oedema   0/357 (0.00%)  1/350 (0.29%) 
Headache   1/357 (0.28%)  0/350 (0.00%) 
Syncope   1/357 (0.28%)  0/350 (0.00%) 
Neuralgia   0/357 (0.00%)  1/350 (0.29%) 
Psychiatric disorders     
Confusional state   0/357 (0.00%)  1/350 (0.29%) 
Renal and urinary disorders     
Renal failure acute   3/357 (0.84%)  1/350 (0.29%) 
Nephrolithiasis   1/357 (0.28%)  1/350 (0.29%) 
Renal failure   1/357 (0.28%)  0/350 (0.00%) 
Urinary retention   1/357 (0.28%)  0/350 (0.00%) 
Renal injury   0/357 (0.00%)  1/350 (0.29%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   3/357 (0.84%)  7/350 (2.00%) 
Aspiration   1/357 (0.28%)  0/350 (0.00%) 
Pleural effusion   1/357 (0.28%)  0/350 (0.00%) 
Pneumonia aspiration   1/357 (0.28%)  1/350 (0.29%) 
Cough   0/357 (0.00%)  1/350 (0.29%) 
Laryngeal obstruction   0/357 (0.00%)  1/350 (0.29%) 
Pulmonary embolism   1/357 (0.28%)  2/350 (0.57%) 
Pneumonitis   0/357 (0.00%)  3/350 (0.86%) 
Vascular disorders     
Circulatory collapse   1/357 (0.28%)  0/350 (0.00%) 
Embolism   2/357 (0.56%)  0/350 (0.00%) 
Hypotension   2/357 (0.56%)  0/350 (0.00%) 
Haemorrhage   1/357 (0.28%)  0/350 (0.00%) 
Peripheral artery thrombosis   1/357 (0.28%)  0/350 (0.00%) 
Thrombosis   1/357 (0.28%)  0/350 (0.00%) 
Venous thrombosis   1/357 (0.28%)  0/350 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Napabucasin + Paclitaxel Placebo + Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   352/357 (98.60%)   338/350 (96.57%) 
Blood and lymphatic system disorders     
Anaemia   126/357 (35.29%)  118/350 (33.71%) 
Neutropenia   37/357 (10.36%)  49/350 (14.00%) 
Leukopenia   22/357 (6.16%)  19/350 (5.43%) 
Gastrointestinal disorders     
Diarrhoea   304/357 (85.15%)  126/350 (36.00%) 
Nausea   178/357 (49.86%)  123/350 (35.14%) 
Abdominal pain   140/357 (39.22%)  93/350 (26.57%) 
Vomiting   135/357 (37.82%)  95/350 (27.14%) 
Constipation   61/357 (17.09%)  78/350 (22.29%) 
Abdominal pain upper   35/357 (9.80%)  40/350 (11.43%) 
Abdominal distension   28/357 (7.84%)  25/350 (7.14%) 
Dysphagia   22/357 (6.16%)  24/350 (6.86%) 
Ascites   18/357 (5.04%)  17/350 (4.86%) 
General disorders     
Fatigue   110/357 (30.81%)  92/350 (26.29%) 
Asthenia   73/357 (20.45%)  73/350 (20.86%) 
Pyrexia   57/357 (15.97%)  40/350 (11.43%) 
Oedema peripheral   38/357 (10.64%)  31/350 (8.86%) 
Infections and infestations     
Urinary tract infection   29/357 (8.12%)  12/350 (3.43%) 
Investigations     
Neutrophil count decreased   48/357 (13.45%)  53/350 (15.14%) 
Weight decreased   41/357 (11.48%)  23/350 (6.57%) 
White blood cell count decreased   35/357 (9.80%)  43/350 (12.29%) 
Metabolism and nutrition disorders     
Decreased appetite   129/357 (36.13%)  103/350 (29.43%) 
Hypokalaemia   29/357 (8.12%)  9/350 (2.57%) 
Hypoalbuminaemia   20/357 (5.60%)  18/350 (5.14%) 
Musculoskeletal and connective tissue disorders     
Back pain   31/357 (8.68%)  33/350 (9.43%) 
Arthralgia   17/357 (4.76%)  28/350 (8.00%) 
Nervous system disorders     
Neuropathy peripheral   46/357 (12.89%)  38/350 (10.86%) 
Peripheral sensory neuropathy   37/357 (10.36%)  47/350 (13.43%) 
Dysgeusia   27/357 (7.56%)  15/350 (4.29%) 
Dizziness   19/357 (5.32%)  19/350 (5.43%) 
Paraesthesia   17/357 (4.76%)  22/350 (6.29%) 
Psychiatric disorders     
Insomnia   30/357 (8.40%)  27/350 (7.71%) 
Renal and urinary disorders     
Chromaturia   47/357 (13.17%)  3/350 (0.86%) 
Respiratory, thoracic and mediastinal disorders     
Cough   35/357 (9.80%)  34/350 (9.71%) 
Dyspnoea   30/357 (8.40%)  37/350 (10.57%) 
Skin and subcutaneous tissue disorders     
Alopecia   73/357 (20.45%)  94/350 (26.86%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marilyn Fontaine
Organization: Sumitomo Dainippon Pharma Oncology
Phone: 617-674-8556
EMail: mfontaine@bostonbiomedical.com
Layout table for additonal information
Responsible Party: Sumitomo Dainippon Pharma Oncology, Inc
ClinicalTrials.gov Identifier: NCT02178956    
Other Study ID Numbers: BBI608-336
2014-000774-18 ( EudraCT Number )
First Submitted: June 27, 2014
First Posted: July 1, 2014
Results First Submitted: March 12, 2021
Results First Posted: May 10, 2021
Last Update Posted: May 10, 2021