Trial · NCT02753127
A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
NCT02753127, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2022-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer. Trials, record NCT02753127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02753127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
- NCT number
- NCT02753127
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,253 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Colorectal Cancer
- Interventions
- Napabucasin, Fluorouracil, Leucovorin, Irinotecan, Bevacizumab
- First posted
- 2016-04-27
- Last updated
- 2023-11-15
- Other registries' IDs
- eudract:2016-001627-31
- Results first posted
- 2022-04-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Randomization to Date of Death from any cause or database cutoff date (28 Apr 2020) (Approximately 43 months) | Overall survival was defined as the time from randomization until death from any cause. Patients who are alive at the time of the interim or the final analyses or who have become lost to follow-up will be censored on the date the patient was last known to be alive. |
| Secondary | Progression-Free Survival (PFS) | Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months) | PFS is defined as the time from randomization to the first objective documentation of disease progression per RECIST 1.1 (PD) or death, whichever comes first. |
| Secondary | Disease Control Rate (DCR) | Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months) | DCR is defined as the percentage of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. The primary estimate of DCR will be based on patients with measurable disease by RECIST 1.1 at randomization |
| Secondary | Objective Response Rate (ORR) | Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months) | ORR is defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1. The primary estimate for ORR will be based on patients with measurable disease by RECIST 1.1 at randomization. |
| Secondary | Mean Change From Baseline for Global Health Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1). | From baseline at Time 2 (Cycle 5 Day 1), approximately 57 days and Time 4 (Cycle 9 Day 1), approximately 113 days | The Quality of Life (QoL) of patients will be assessed using European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) (EORTC QLQ-30) while the patient remains on study treatment (FOLFIRI with or without BBI-608). EORTC QLQ-30 is used to assess the overall quality of life in cancer patients using 28 questions with a 4 point scale. (1 'Not at all' to 4'Very Much'); 2 questions use a 7-point sale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life. |
| Secondary | Mean Change From Baseline for Physical Functioning Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1). | From baseline at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1) | The Quality of Life (QoL) of patients will be assessed using European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) (EORTC QLQ-30) while the patient remains on study treatment (FOLFIRI with or without BBI-608). EORTC QLQ-30 is used to assess the overall quality of life in cancer patients using 28 questions with a 4 point scale. (1 'Not at all' to 4'Very Much'); 2 questions use a 7-point sale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life. |
| Secondary | Number of Patients With Adverse Events in the General Population | All adverse event are collected from date of signed informed consent until 30 days after protocol treatment discontinuation. Outcome followed until study discontinuation up to 4 years | All patients who have received at least one dose of either BBI-608 or FOLFIRI will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Randomization to Date of Death from any cause or database cutoff date (28 Apr 2020) (Approximately 43 months) | The pSTAT3 subpopulations will be defined by the results of a Clinical Trial Assay (CTA) for a specimen with an age within a defined cut-section stability (CSS) window.~A patient with positive pSTAT3 status within a defined CSS window is the one with pSTAT3 positive designated by CTA with specimen age up to 6 months at interim analysis or up to the final CSS window at final analysis. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months) | The pSTAT3 subpopulations will be defined by the results of a Clinical Trial Assay (CTA) for a specimen with an age within a defined cut-section stability (CSS) window.~A patient with positive pSTAT3 status within a defined CSS window is the one with pSTAT3 positive designated by CTA with specimen age up to 6 months at interim analysis or up to the final CSS window at final analysis. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months) | Analysis population of DCR will be based on patients with measurable disease by RECIST 1.1 at randomization. A patient with positive pSTAT3 status within a defined CSS window is the one with pSTAT3 positive designated by CTA with specimen age up to 6 months at interim analysis or up to the final CSS window at final analysis. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | Randomization to Date of Death or until the date of first documented objective disease progression or database cutoff date (28 Apr 2020) (Approximately 43 months) | Analysis set for ORR will be based on patients with measurable disease by RECIST 1.1 at randomization. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline for Global Health Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1). | From baseline at Time 2 (Cycle 5 Day 1), approximately 57 days and Time 4 (Cycle 9 Day 1), approximately 113 days | The number of patients is with at least one valid assessment at each analysis window | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for Physical Functioning Status at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1). | From baseline at Time 2 (Cycle 5 Day 1) and Time 4 (Cycle 9 Day 1) | The number of patients is with at least one valid assessment at each analysis window. | QOL score on a scale | MEAN |
| SECONDARY | Number of Patients With Adverse Events in the General Population | All adverse event are collected from date of signed informed consent until 30 days after protocol treatment discontinuation. Outcome followed until study discontinuation up to 4 years | All patients who received at least 1 dose of study drug (BBI-608 and/or FOLFIRI) with treatment assignment designated according to the actual study treatment received. Adverse event is analyzed in the SAS population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Napabucasin + FOLFIRI ± Bevacizumab | Overall Survival (OS), General Population(GP) | 14.29 | 95% Confidence Interval 13.34 to 15.7 | months |
| Overall Survival (OS) | FOLFIRI ± Bevacizumab | Overall Survival (OS), General Population(GP) | 13.83 | 95% Confidence Interval 12.42 to 15.28 | months |
| Overall Survival (OS) | Napabucasin + FOLFIRI ± Bevacizumab | Overall Survival (OS), ITT-pSTAT3(+) | 13.17 | 95% Confidence Interval 11.30 to 15.31 | months |
| Overall Survival (OS) | FOLFIRI ± Bevacizumab | Overall Survival (OS), ITT-pSTAT3(+) | 12.12 | 95% Confidence Interval 11.24 to 14.06 | months |
| Progression-Free Survival (PFS) | Napabucasin + FOLFIRI ± Bevacizumab | Progression-Free Survival (PFS), General Population(GP) | 5.55 | 95% Confidence Interval 5.39 to 5.78 | months |
| Progression-Free Survival (PFS) | FOLFIRI ± Bevacizumab | Progression-Free Survival (PFS), General Population(GP) | 5.62 | 95% Confidence Interval 5.45 to 6.34 | months |
| Progression-Free Survival (PFS) | Napabucasin + FOLFIRI ± Bevacizumab | Progression-Free Survival (PFS) , ITT-pSTAT3(+) | 5.39 | 95% Confidence Interval 4.14 to 5.62 | months |
| Progression-Free Survival (PFS) | FOLFIRI ± Bevacizumab | Progression-Free Survival (PFS) , ITT-pSTAT3(+) | 5.55 | 95% Confidence Interval 4.44 to 5.91 | months |
| Disease Control Rate (DCR) | Napabucasin + FOLFIRI ± Bevacizumab | Disease Control Rate (DCR), General Population(GP) | 69.6 | 95% Confidence Interval 65.8 to 73.3 | percentage of participants |
| Disease Control Rate (DCR) | FOLFIRI ± Bevacizumab | Disease Control Rate (DCR), General Population(GP) | 69.1 | 95% Confidence Interval 65.3 to 72.8 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Napabucasin + FOLFIRI ± Bevacizumab | 624 | |
| Overall Study | STARTED | FOLFIRI ± Bevacizumab | 629 | |
| Overall Study | Discontinued Due to Death | Napabucasin + FOLFIRI ± Bevacizumab | 507 | |
| Overall Study | Discontinued Due to Death | FOLFIRI ± Bevacizumab | 499 | |
| Overall Study | Completion of Survival Follow-Up Due to Study Completion | Napabucasin + FOLFIRI ± Bevacizumab | 64 | |
| Overall Study | Completion of Survival Follow-Up Due to Study Completion | FOLFIRI ± Bevacizumab | 62 | |
| Overall Study | COMPLETED | Napabucasin + FOLFIRI ± Bevacizumab | 571 | |
| Overall Study | COMPLETED | FOLFIRI ± Bevacizumab | 561 | |
| Overall Study | NOT COMPLETED | Napabucasin + FOLFIRI ± Bevacizumab | 53 | |
| Overall Study | NOT COMPLETED | FOLFIRI ± Bevacizumab | 68 |
Source ClinicalTrials.gov
Adverse events602
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Napabucasin + FOLFIRI ± Bevacizumab | 154 | 622 | |
| other | Anaemia | Blood and lymphatic system disorders | FOLFIRI ± Bevacizumab | 148 | 610 | |
| other | Neutropenia | Blood and lymphatic system disorders | Napabucasin + FOLFIRI ± Bevacizumab | 154 | 622 | |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFIRI ± Bevacizumab | 165 | 610 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Napabucasin + FOLFIRI ± Bevacizumab | 36 | 622 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFIRI ± Bevacizumab | 24 | 610 | |
| other | Leukopenia | Blood and lymphatic system disorders | Napabucasin + FOLFIRI ± Bevacizumab | 32 | 622 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFIRI ± Bevacizumab | 43 | 610 | |
| other | Diarrhoea | Gastrointestinal disorders | Napabucasin + FOLFIRI ± Bevacizumab | 526 | 622 | |
| other | Diarrhoea | Gastrointestinal disorders | FOLFIRI ± Bevacizumab | 329 | 610 |
1 to 10 of 602Source ClinicalTrials.gov
See all 602 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Napabucasin + FOLFIRI ± Bevacizumab | 507 | 624 |
| Total, all-cause mortality | FOLFIRI ± Bevacizumab | 499 | 629 |
| Total, other adverse events | Napabucasin + FOLFIRI ± Bevacizumab | 619 | 622 |
| Total, other adverse events | FOLFIRI ± Bevacizumab | 602 | 610 |
| Total, serious adverse events | Napabucasin + FOLFIRI ± Bevacizumab | 234 | 622 |
| Total, serious adverse events | FOLFIRI ± Bevacizumab | 201 | 610 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Napabucasin + FOLFIRI ± Bevacizumab vs FOLFIRI ± Bevacizumab: deaths from any cause | Trial comparisons |
| Napabucasin + FOLFIRI ± Bevacizumab vs FOLFIRI ± Bevacizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02753127
GET https://conductscience.org/api/trials/v1/NCT02753127/results?page=2