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A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01776307
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : June 18, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Oncology, Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: BBI608
Drug: Panitumumab
Drug: Capecitabine
Drug: Cetuximab
Enrollment 200
Recruitment Details 200 participants were enrolled between March 2012 and July 2017.
Pre-assignment Details Patients who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks
Period Title: Overall Study
Started 49 75 76
Completed 49 75 75
Not Completed 0 0 1
Reason Not Completed
Not dosed             0             0             1
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine Total
Hide Arm/Group Description All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously All participants who were enrolled to Arm B to receive napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle All participants who were enrolled to Arm C to receive napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks Total of all reporting groups
Overall Number of Baseline Participants 49 75 75 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 75 participants 75 participants 199 participants
56.3  (10.37) 59.7  (11.94) 58.1  (11.20) 58.3  (11.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 75 participants 75 participants 199 participants
Female
27
  55.1%
35
  46.7%
24
  32.0%
86
  43.2%
Male
22
  44.9%
40
  53.3%
51
  68.0%
113
  56.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 75 participants 75 participants 199 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   6.1%
0
   0.0%
3
   4.0%
6
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.1%
4
   5.3%
8
  10.7%
14
   7.0%
White
39
  79.6%
69
  92.0%
64
  85.3%
172
  86.4%
More than one race
3
   6.1%
2
   2.7%
0
   0.0%
5
   2.5%
Unknown or Not Reported
2
   4.1%
0
   0.0%
0
   0.0%
2
   1.0%
1.Primary Outcome
Title Disease Control Rate
Hide Description Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine
Time Frame From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 1 cycle of study treatment and had at least 1 disease assessment following the initiation of therapy. Patients missing imaging assessment following the initiation of treatment are not included in the assessment for DCR.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients in this group had a baseline scan and at least one assessment approximately 8 weeks from baseline.
Overall Number of Participants Analyzed 29 41 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.5
(17.9 to 54.3)
36.6
(22.1 to 53.1)
25.6
(13.0 to 42.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin Plus Cetuximab, Napabucasin Plus Panitumumab, Napabucasin Plus Capecitabine
Comments [Not Specified]
Type of Statistical Test Other
Comments Descriptive analysis for investigational arms; no comparator analysis
Other Statistical Analysis The exact 95% confidence interval is based on the Clopper-Pearson method.
2.Secondary Outcome
Title Progression Free Survival
Hide Description The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on Progression Free Survival (PFS) of patients with advanced colorectal cancer.
Time Frame The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle . Patients in this group had a baseline scan and at least one on study scan or died from any cause.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients in this group had a baseline scan and at least one on study scan or died from any cause.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients in this group had a baseline scan and at least one on study scan or died from any cause
Overall Number of Participants Analyzed 49 75 75
Median (95% Confidence Interval)
Unit of Measure: months
1.87
(1.81 to 3.65)
2.27
(2.04 to 3.58)
1.94
(1.71 to 2.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin Plus Cetuximab, Napabucasin Plus Panitumumab, Napabucasin Plus Capecitabine
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimates provided for investigational arms; no comparator analysis
Other Statistical Analysis Estimated from Kaplan Meier Curve
3.Secondary Outcome
Title Overall Survival
Hide Description The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on the Overall Survival of patients with advanced colorectal cancer
Time Frame 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks.
Overall Number of Participants Analyzed 49 75 75
Median (95% Confidence Interval)
Unit of Measure: Months
7.79
(5.49 to 8.54)
9.10
(5.88 to 12.48)
6.34
(5.13 to 11.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Napabucasin Plus Cetuximab, Napabucasin Plus Panitumumab, Napabucasin Plus Capecitabine
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimates provided for investigational arms; no comparator analysis
Other Statistical Analysis Estimated from Kaplan Meier Curve
4.Secondary Outcome
Title Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
Hide Description To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 5 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 6 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
661
(77.9%)
468 [1] 
(NA%)
[1]
Not calculated
5.Secondary Outcome
Title Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
Hide Description To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 21 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 5 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
627
(77.3%)
398 [1] 
(NA%)
[1]
Not calculated
6.Secondary Outcome
Title Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
Hide Description To determine the maximum concentration of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 21 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus panitumumab & Napabucasin plus capecitabine: No evaluable patients dosed at 240mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 1 0 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
494 [1] 
(NA%)
[1]
Not calculated
7.Secondary Outcome
Title Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
Hide Description To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 5 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 0 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1020
(50.6%)
858
(34.5%)
8.Secondary Outcome
Title Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
Hide Description To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 21 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 0 3 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1060
(23.0%)
789
(72.0%)
9.Secondary Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
Hide Description To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 5 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 6 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
3380
(83.3%)
2730 [1] 
(NA%)
[1]
Not calculated
10.Secondary Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
Hide Description To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 21 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 480mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 5 1 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
2930
(137%)
2630 [1] 
(NA%)
[1]
Not calculated
11.Secondary Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
Hide Description To determine the area under the plasma concentration vs. time curve of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 21 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus panitumumab and Napabucasin plus capecitabine: No evaluable patients dosed at 240mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 240mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 1 0 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
2870 [1] 
(NA%)
[1]
Not calculated
12.Secondary Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
Hide Description To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 5 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 0 4 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
5420
(36.3%)
5350
(38.7%)
13.Secondary Outcome
Title Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
Hide Description To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Time Frame Blood samples drawn on day 21 during the first study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group took napabucasin 500mg twice daily and provided blood samples for analysis.
Overall Number of Participants Analyzed 0 3 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
6290
(6.71%)
4720
(48.2%)
14.Secondary Outcome
Title Pharmacodynamics
Hide Description To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin
Time Frame During the first 28 days of the study cycle
Hide Outcome Measure Data
Hide Analysis Population Description
No on-treatment biopsies were performed therefore no pharmacodynamic testing on tumor tissue was conducted.
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle . Patients included in this group needed to have on treatment biopsy
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group needed to have on treatment biopsy
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group needed to have on treatment biopsy.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Patients With Adverse Events and Serious Adverse Events
Hide Description Assessment of safety of napabucasin given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events
Time Frame The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description:
Napabucasin administered orally, twice daily, in combination with weekly cetuximab administered intravenously on Days 5, 12, 19, and 26 of each 28 day study cycle. Patients included in this group received at least one dose of study drug.
Napabucasin administered orally, twice daily, in combination with panitumumab administered intravenously on Days 8 and 22 of each 28 day study cycle. Patients included in this group received at least one dose of study drug.
Napabucasin administered orally, twice daily, in combination with capecitabine administered twice daily on Days 8-21 every three weeks. Patients included in this group received at least one dose of study drug.
Overall Number of Participants Analyzed 49 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
49
 100.0%
75
 100.0%
75
 100.0%
Time Frame Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, assessed up to 60 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Hide Arm/Group Description All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with panitumumab administered intravenously on day 8 and 22 of each 28 day cycle All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with capecitabine administered twice daily on days 8-21 every three weeks
All-Cause Mortality
Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/49 (91.84%)   70/75 (93.33%)   72/75 (96.00%) 
Hide Serious Adverse Events
Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/49 (34.69%)   29/75 (38.67%)   26/75 (34.67%) 
Blood and lymphatic system disorders       
Anaemia  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Cardiac disorders       
Atrial fibrillation  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Pericardial effusion  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  4/49 (8.16%)  4/75 (5.33%)  5/75 (6.67%) 
Diarrhoea  1  4/49 (8.16%)  0/75 (0.00%)  2/75 (2.67%) 
Nausea  1  2/49 (4.08%)  1/75 (1.33%)  0/75 (0.00%) 
Constipation  1  1/49 (2.04%)  0/75 (0.00%)  1/75 (1.33%) 
Gastrointestinal haemorrhage  1  1/49 (2.04%)  2/75 (2.67%)  1/75 (1.33%) 
Large intestine perforation  1  1/49 (2.04%)  0/75 (0.00%)  0/75 (0.00%) 
Small intestinal obstruction  1  1/49 (2.04%)  3/75 (4.00%)  2/75 (2.67%) 
Vomiting  1  1/49 (2.04%)  2/75 (2.67%)  2/75 (2.67%) 
Ascites  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Colitis  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Intestinal obstruction  1  0/49 (0.00%)  1/75 (1.33%)  1/75 (1.33%) 
Pancreatitis acute  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
General disorders       
Disease progression  1  3/49 (6.12%)  3/75 (4.00%)  0/75 (0.00%) 
Pyrexia  1  0/49 (0.00%)  3/75 (4.00%)  0/75 (0.00%) 
Chest pain  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Device dislocation  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Oedema peripheral  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Asthenia  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Pain  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Hepatobiliary disorders       
Bile duct obstruction  1  1/49 (2.04%)  0/75 (0.00%)  3/75 (4.00%) 
Hepatic failure  1  1/49 (2.04%)  0/75 (0.00%)  0/75 (0.00%) 
Cholangitis  1  0/49 (0.00%)  1/75 (1.33%)  1/75 (1.33%) 
Hyperbilirubinaemia  1  0/49 (0.00%)  1/75 (1.33%)  1/75 (1.33%) 
Immune system disorders       
Anaphylactic reaction  1  1/49 (2.04%)  0/75 (0.00%)  0/75 (0.00%) 
Infections and infestations       
Sepsis  1  1/49 (2.04%)  2/75 (2.67%)  1/75 (1.33%) 
Clostridium difficile infection  1  0/49 (0.00%)  1/75 (1.33%)  1/75 (1.33%) 
Urinary tract infection  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Pneumonia  1  0/49 (0.00%)  0/75 (0.00%)  2/75 (2.67%) 
Injury, poisoning and procedural complications       
Renal haematoma  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Investigations       
Blood bilirubin increased  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Blood creatinine increased  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/49 (2.04%)  3/75 (4.00%)  2/75 (2.67%) 
Hypoglycaemia  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Hypomagnesaemia  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Hypokalaemia  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Flank pain  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Pain in jaw  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Bone pain  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant neoplasm progression  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Nervous system disorders       
Haemorrhage intracranial  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Hemiparesis  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Hepatic encephalopathy  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Renal and urinary disorders       
Acute kidney injury  1  0/49 (0.00%)  2/75 (2.67%)  3/75 (4.00%) 
Haematuria  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/49 (4.08%)  1/75 (1.33%)  1/75 (1.33%) 
Acute respiratory failure  1  1/49 (2.04%)  0/75 (0.00%)  0/75 (0.00%) 
Pulmonary embolism  1  1/49 (2.04%)  2/75 (2.67%)  0/75 (0.00%) 
Pleural effusion  1  0/49 (0.00%)  0/75 (0.00%)  3/75 (4.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Skin disorder  1  0/49 (0.00%)  1/75 (1.33%)  0/75 (0.00%) 
Vascular disorders       
Hypotension  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
Thrombosis  1  0/49 (0.00%)  0/75 (0.00%)  1/75 (1.33%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Napabucasin Plus Cetuximab Napabucasin Plus Panitumumab Napabucasin Plus Capecitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/49 (100.00%)   75/75 (100.00%)   75/75 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  9/49 (18.37%)  16/75 (21.33%)  16/75 (21.33%) 
Lymphopenia  1  1/49 (2.04%)  9/75 (12.00%)  18/75 (24.00%) 
Thrombocytopenia  1  1/49 (2.04%)  6/75 (8.00%)  5/75 (6.67%) 
Leukopenia  1  1/49 (2.04%)  4/75 (5.33%)  5/75 (6.67%) 
Eye disorders       
Vision blurred  1  4/49 (8.16%)  0/75 (0.00%)  0/75 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  37/49 (75.51%)  58/75 (77.33%)  61/75 (81.33%) 
Abdominal pain  1  25/49 (51.02%)  26/75 (34.67%)  30/75 (40.00%) 
Nausea  1  22/49 (44.90%)  39/75 (52.00%)  47/75 (62.67%) 
Vomiting  1  22/49 (44.90%)  27/75 (36.00%)  27/75 (36.00%) 
Constipation  1  15/49 (30.61%)  9/75 (12.00%)  10/75 (13.33%) 
Abdominal pain upper  1  6/49 (12.24%)  6/75 (8.00%)  7/75 (9.33%) 
Ascites  1  2/49 (4.08%)  5/75 (6.67%)  3/75 (4.00%) 
Abdominal distension  1  3/49 (6.12%)  3/75 (4.00%)  6/75 (8.00%) 
Stomatitis  1  1/49 (2.04%)  5/75 (6.67%)  4/75 (5.33%) 
General disorders       
Fatigue  1  20/49 (40.82%)  43/75 (57.33%)  36/75 (48.00%) 
Oedema peripheral  1  6/49 (12.24%)  6/75 (8.00%)  8/75 (10.67%) 
Pyrexia  1  6/49 (12.24%)  5/75 (6.67%)  7/75 (9.33%) 
Mucosal inflammation  1  5/49 (10.20%)  3/75 (4.00%)  3/75 (4.00%) 
Chills  1  3/49 (6.12%)  6/75 (8.00%)  3/75 (4.00%) 
Disease progression  1  3/49 (6.12%)  3/75 (4.00%)  0/75 (0.00%) 
Asthenia  1  0/49 (0.00%)  5/75 (6.67%)  7/75 (9.33%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  2/49 (4.08%)  1/75 (1.33%)  7/75 (9.33%) 
Infections and infestations       
Urinary tract infection  1  4/49 (8.16%)  15/75 (20.00%)  6/75 (8.00%) 
Injury, poisoning and procedural complications       
Infusion related reaction  1  3/49 (6.12%)  1/75 (1.33%)  0/75 (0.00%) 
Investigations       
Blood alkaline phosphatase increased  1  7/49 (14.29%)  9/75 (12.00%)  12/75 (16.00%) 
Aspartate aminotransferase increased  1  6/49 (12.24%)  6/75 (8.00%)  13/75 (17.33%) 
Blood bilirubin increased  1  4/49 (8.16%)  6/75 (8.00%)  1/75 (1.33%) 
Alanine aminotransferase increased  1  4/49 (8.16%)  5/75 (6.67%)  5/75 (6.67%) 
Blood lactate dehydrogenase increased  1  4/49 (8.16%)  1/75 (1.33%)  0/75 (0.00%) 
Blood creatinine increased  1  3/49 (6.12%)  1/75 (1.33%)  5/75 (6.67%) 
Weight decreased  1  1/49 (2.04%)  5/75 (6.67%)  5/75 (6.67%) 
Protein total decreased  1  0/49 (0.00%)  5/75 (6.67%)  0/75 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  15/49 (30.61%)  24/75 (32.00%)  23/75 (30.67%) 
Hypomagnesaemia  1  15/49 (30.61%)  23/75 (30.67%)  4/75 (5.33%) 
Hypokalaemia  1  12/49 (24.49%)  23/75 (30.67%)  15/75 (20.00%) 
Hypoalbuminaemia  1  8/49 (16.33%)  8/75 (10.67%)  18/75 (24.00%) 
Hypophosphataemia  1  7/49 (14.29%)  5/75 (6.67%)  0/75 (0.00%) 
Dehydration  1  6/49 (12.24%)  7/75 (9.33%)  10/75 (13.33%) 
Hyponatraemia  1  5/49 (10.20%)  2/75 (2.67%)  12/75 (16.00%) 
Hyperglycaemia  1  4/49 (8.16%)  15/75 (20.00%)  22/75 (29.33%) 
Hypocalcaemia  1  2/49 (4.08%)  5/75 (6.67%)  2/75 (2.67%) 
Hypouricaemia  1  10/49 (20.41%)  4/75 (5.33%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  4/49 (8.16%)  6/75 (8.00%)  5/75 (6.67%) 
Muscle spasms  1  4/49 (8.16%)  4/75 (5.33%)  5/75 (6.67%) 
Musculoskeletal pain  1  4/49 (8.16%)  1/75 (1.33%)  2/75 (2.67%) 
Muscular weakness  1  3/49 (6.12%)  2/75 (2.67%)  2/75 (2.67%) 
Pain in extremity  1  3/49 (6.12%)  1/75 (1.33%)  3/75 (4.00%) 
Arthralgia  1  2/49 (4.08%)  2/75 (2.67%)  4/75 (5.33%) 
Nervous system disorders       
Dizziness  1  7/49 (14.29%)  7/75 (9.33%)  9/75 (12.00%) 
Headache  1  5/49 (10.20%)  6/75 (8.00%)  3/75 (4.00%) 
Psychiatric disorders       
Insomnia  1  4/49 (8.16%)  3/75 (4.00%)  3/75 (4.00%) 
Anxiety  1  3/49 (6.12%)  3/75 (4.00%)  3/75 (4.00%) 
Depression  1  1/49 (2.04%)  5/75 (6.67%)  4/75 (5.33%) 
Renal and urinary disorders       
Chromaturia  1  11/49 (22.45%)  12/75 (16.00%)  10/75 (13.33%) 
Proteinuria  1  5/49 (10.20%)  11/75 (14.67%)  18/75 (24.00%) 
Ketonuria  1  3/49 (6.12%)  11/75 (14.67%)  17/75 (22.67%) 
Haematuria  1  2/49 (4.08%)  9/75 (12.00%)  10/75 (13.33%) 
Glycosuria  1  0/49 (0.00%)  2/75 (2.67%)  6/75 (8.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  7/49 (14.29%)  13/75 (17.33%)  13/75 (17.33%) 
Cough  1  2/49 (4.08%)  9/75 (12.00%)  10/75 (13.33%) 
Pulmonary embolism  1  2/49 (4.08%)  4/75 (5.33%)  0/75 (0.00%) 
Pleural effusion  1  0/49 (0.00%)  1/75 (1.33%)  5/75 (6.67%) 
Skin and subcutaneous tissue disorders       
Dermatitis acneiform  1  10/49 (20.41%)  13/75 (17.33%)  0/75 (0.00%) 
Dry skin  1  10/49 (20.41%)  6/75 (8.00%)  3/75 (4.00%) 
Rash  1  9/49 (18.37%)  21/75 (28.00%)  5/75 (6.67%) 
Rash maculo-papular  1  6/49 (12.24%)  9/75 (12.00%)  1/75 (1.33%) 
Palmar-plantar erythrodysaethesia syndrome  1  2/49 (4.08%)  5/75 (6.67%)  11/75 (14.67%) 
Vascular disorders       
Hypotension  1  3/49 (6.12%)  4/75 (5.33%)  3/75 (4.00%) 
1
Term from vocabulary, MedDRA 18.0
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.
The sponsor can review results communications prior to public release and embargo communications of results up to 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tegan Nguyen
Organization: Sumitomo Dainippon Pharma Oncology
Phone: 617-674-8745
EMail: tnguyen@bostonbiomedical.com
Layout table for additonal information
Responsible Party: Sumitomo Dainippon Pharma Oncology, Inc
ClinicalTrials.gov Identifier: NCT01776307    
Other Study ID Numbers: BBI608-224
First Submitted: January 21, 2013
First Posted: January 28, 2013
Results First Submitted: May 20, 2021
Results First Posted: June 18, 2021
Last Update Posted: June 18, 2021