Colorectal Cancer
Conditions
Keywords
BBI608
Brief summary
This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
Detailed description
This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.
Interventions
DRUGBBI608
BBI608 is administered at 500 mg po bid continuously.
DRUGPanitumumab
Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
DRUGCapecitabine
Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
DRUGCetuximab
Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH), Good Clinical Practice(GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures. * A histologically or cytologically confirmed colorectal cancer that is metastatic, unresectable, or recurrent. * Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan. * Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have colorectal cancer which is K-Ras wild-type. * ≥ 18 years of age. * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Karnofsky performance Status ≥ 70% * Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose. * Females of childbearing potential must have a negative serum pregnancy test. * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease. * Hemoglobin (Hgb) ≥ 10 g/dl. * Total bilirubin ≤ 1.5 × ULN. * Creatinine ≤ 1.5 × ULN or creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal. * Absolute neutrophil count ≥ 1.5 x 10\^9/L. * Platelets ≥ 100 x 10\^9/L. * Life expectancy ≥ 3 months.
Exclusion criteria
* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI608. * Surgery within 4 weeks prior to first dose. * Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated. * Pregnant or breastfeeding * Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection) * Unable or unwilling to swallow BBI608 capsules daily. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 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 | The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on Progression Free Survival (PFS) of patients with advanced colorectal cancer. |
| Overall Survival | 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months. | The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on the Overall Survival of patients with advanced colorectal cancer |
| Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle | Blood samples drawn on day 5 during the first study cycle | 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. |
| Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle | Blood samples drawn on day 21 during the first study cycle | 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. |
| Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle | Blood samples drawn on day 21 during the first study cycle | 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. |
| Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle | Blood samples drawn on day 5 during the first study cycle | 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. |
| Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle | Blood samples drawn on day 21 during the first study cycle | 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. |
| Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle | Blood samples drawn on day 5 during the first study cycle | 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. |
| Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle | Blood samples drawn on day 21 during the first study cycle | 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. |
| Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle | Blood samples drawn on day 21 during the first study cycle | 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. |
| Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle | Blood samples drawn on day 5 during the first study cycle | 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. |
| Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle | Blood samples drawn on day 21 during the first study cycle | 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. |
| Pharmacodynamics | During the first 28 days of the study cycle | To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin |
| Number of Patients With Adverse Events and Serious Adverse Events | 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. | 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 |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Napabucasin Plus Cetuximab All participants who were enrolled to Arm A to receive napabucasin administered orally, twice daily in combination with weekly cetuximab administered intravenously | 49 |
| Napabucasin Plus Panitumumab 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 | 75 |
| Napabucasin Plus Capecitabine 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 | 75 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Not dosed | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Napabucasin Plus Cetuximab | Napabucasin Plus Panitumumab | Napabucasin Plus Capecitabine | Total |
|---|---|---|---|---|
| Age, Customized | 56.3 years STANDARD_DEVIATION 10.37 | 59.7 years STANDARD_DEVIATION 11.94 | 58.1 years STANDARD_DEVIATION 11.2 | 58.3 years STANDARD_DEVIATION 11.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 39 Participants | 69 Participants | 64 Participants | 172 Participants |
| Sex: Female, Male Female | 27 Participants | 35 Participants | 24 Participants | 86 Participants |
| Sex: Female, Male Male | 22 Participants | 40 Participants | 51 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 45 / 49 | 70 / 75 | 72 / 75 |
| other Total, other adverse events | 49 / 49 | 75 / 75 | 75 / 75 |
| serious Total, serious adverse events | 17 / 49 | 29 / 75 | 26 / 75 |
Outcome results
Primary
Disease Control Rate
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Napabucasin Plus Cetuximab | Disease Control Rate | 34.5 Percentage of participants |
| Napabucasin Plus Panitumumab | Disease Control Rate | 36.6 Percentage of participants |
| Napabucasin Plus Capecitabine | Disease Control Rate | 25.6 Percentage of participants |
Secondary
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
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
Population: Napabucasin plus panitumumab and Napabucasin plus capecitabine: No evaluable patients dosed at 240mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Napabucasin Plus Cetuximab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle | 2870 h*ng/mL |
Secondary
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
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
Population: Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Cetuximab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle | 2930 h*ng/mL | Geometric Coefficient of Variation 137 |
| Napabucasin Plus Panitumumab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle | 2630 h*ng/mL | — |
Secondary
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
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
Population: Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Cetuximab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle | 3380 h*ng/mL | Geometric Coefficient of Variation 83.3 |
| Napabucasin Plus Panitumumab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle | 2730 h*ng/mL | — |
Secondary
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
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
Population: Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Panitumumab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle | 6290 h*ng/mL | Geometric Coefficient of Variation 6.71 |
| Napabucasin Plus Capecitabine | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle | 4720 h*ng/mL | Geometric Coefficient of Variation 48.2 |
Secondary
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
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
Population: Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Panitumumab | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle | 5420 h*ng/mL | Geometric Coefficient of Variation 36.3 |
| Napabucasin Plus Capecitabine | Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle | 5350 h*ng/mL | Geometric Coefficient of Variation 38.7 |
Secondary
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
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
Population: Napabucasin plus panitumumab \& Napabucasin plus capecitabine: No evaluable patients dosed at 240mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Napabucasin Plus Cetuximab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle | 494 ng/mL |
Secondary
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
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
Population: Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Cetuximab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle | 627 ng/mL | Geometric Coefficient of Variation 77.3 |
| Napabucasin Plus Panitumumab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle | 398 ng/mL | — |
Secondary
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
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
Population: Napabucasin plus capecitabine: No evaluable patients dosed at 480mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Cetuximab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle | 661 ng/mL | Geometric Coefficient of Variation 77.9 |
| Napabucasin Plus Panitumumab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle | 468 ng/mL | — |
Secondary
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
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
Population: Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Panitumumab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle | 1060 ng/mL | Geometric Coefficient of Variation 23 |
| Napabucasin Plus Capecitabine | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle | 789 ng/mL | Geometric Coefficient of Variation 72 |
Secondary
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
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
Population: Napabucasin plus cetuximab: No evaluable patients dosed at 500mg twice daily.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Panitumumab | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle | 1020 ng/mL | Geometric Coefficient of Variation 50.6 |
| Napabucasin Plus Capecitabine | Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle | 858 ng/mL | Geometric Coefficient of Variation 34.5 |
Secondary
Number of Patients With Adverse Events and Serious Adverse Events
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Napabucasin Plus Cetuximab | Number of Patients With Adverse Events and Serious Adverse Events | 49 Participants |
| Napabucasin Plus Panitumumab | Number of Patients With Adverse Events and Serious Adverse Events | 75 Participants |
| Napabucasin Plus Capecitabine | Number of Patients With Adverse Events and Serious Adverse Events | 75 Participants |
Secondary
Overall Survival
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Napabucasin Plus Cetuximab | Overall Survival | 7.79 Months |
| Napabucasin Plus Panitumumab | Overall Survival | 9.10 Months |
| Napabucasin Plus Capecitabine | Overall Survival | 6.34 Months |
Secondary
Pharmacodynamics
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
Population: No on-treatment biopsies were performed therefore no pharmacodynamic testing on tumor tissue was conducted.
Secondary
Progression Free Survival
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Napabucasin Plus Cetuximab | Progression Free Survival | 1.87 months |
| Napabucasin Plus Panitumumab | Progression Free Survival | 2.27 months |
| Napabucasin Plus Capecitabine | Progression Free Survival | 1.94 months |