Trial · NCT02178956

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

NCT02178956, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2021-05-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer. Trials, record NCT02178956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02178956

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
NCT number: NCT02178956
Status: Completed
Phases: Phase 3
Enrollment: 714 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
Interventions: BBI608, Paclitaxel, Placebo
First posted: 2014-07-01
Last updated: 2023-11-15
Other registries' IDs: eudract:2014-000774-18
Results first posted: 2021-05-10

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	36 months	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.
Secondary	Progression Free Survival	36 months	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.
Secondary	Objective Response Rate	36 months	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.
Secondary	Disease Control Rate	36 months	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.
Secondary	Number of Patients With Adverse Events	36 months	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Survival	36 months	Months	MEDIAN
SECONDARY	Progression Free Survival	36 months	Months	MEDIAN
SECONDARY	Objective Response Rate	36 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease Control Rate	36 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Adverse Events	36 months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival	Napabucasin + Paclitaxel	6.93	95% Confidence Interval 6.28 to 7.69	Months
Overall Survival	Placebo + Paclitaxel	7.36	95% Confidence Interval 6.64 to 8.15	Months
Progression Free Survival	Napabucasin + Paclitaxel	3.55	95% Confidence Interval 3.22 to 3.68	Months
Progression Free Survival	Placebo + Paclitaxel	3.68	95% Confidence Interval 3.48 to 3.71	Months
Objective Response Rate	Napabucasin + Paclitaxel	16		Participants
Objective Response Rate	Placebo + Paclitaxel	18		Participants
Disease Control Rate	Napabucasin + Paclitaxel	55		Participants
Disease Control Rate	Placebo + Paclitaxel	58		Participants
Number of Patients With Adverse Events	Napabucasin + Paclitaxel	352		Participants
Number of Patients With Adverse Events	Placebo + Paclitaxel	338		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Napabucasin + Paclitaxel	357
Overall Study	STARTED	Placebo + Paclitaxel	357
Overall Study	COMPLETED	Napabucasin + Paclitaxel	286
Overall Study	COMPLETED	Placebo + Paclitaxel	279
Overall Study	NOT COMPLETED	Napabucasin + Paclitaxel	71
Overall Study	NOT COMPLETED	Placebo + Paclitaxel	78

Source ClinicalTrials.gov

Adverse events342

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
other	Diarrhoea	Gastrointestinal disorders	Napabucasin + Paclitaxel	304	357
other	Diarrhoea	Gastrointestinal disorders	Placebo + Paclitaxel	126	350
other	Nausea	Gastrointestinal disorders	Napabucasin + Paclitaxel	178	357
other	Nausea	Gastrointestinal disorders	Placebo + Paclitaxel	123	350
other	Abdominal pain	Gastrointestinal disorders	Napabucasin + Paclitaxel	140	357
other	Abdominal pain	Gastrointestinal disorders	Placebo + Paclitaxel	93	350
other	Vomiting	Gastrointestinal disorders	Napabucasin + Paclitaxel	135	357
other	Vomiting	Gastrointestinal disorders	Placebo + Paclitaxel	95	350
other	Constipation	Gastrointestinal disorders	Napabucasin + Paclitaxel	61	357
other	Constipation	Gastrointestinal disorders	Placebo + Paclitaxel	78	350

1 to 10 of 342Source ClinicalTrials.gov

See all 342 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Napabucasin + Paclitaxel	286	357
Total, all-cause mortality	Placebo + Paclitaxel	275	350
Total, other adverse events	Napabucasin + Paclitaxel	352	357
Total, other adverse events	Placebo + Paclitaxel	338	350
Total, serious adverse events	Napabucasin + Paclitaxel	125	357
Total, serious adverse events	Placebo + Paclitaxel	101	350

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 comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Napabucasin + Paclitaxel vs Placebo + Paclitaxel: Number of Patients With Adverse Events	Trial comparisons
Napabucasin + Paclitaxel vs Placebo + Paclitaxel: Objective Response Rate	Trial comparisons
Napabucasin + Paclitaxel vs Placebo + Paclitaxel: Disease Control Rate	Trial comparisons
Napabucasin + Paclitaxel vs Placebo + Paclitaxel: deaths from any cause	Trial comparisons
Napabucasin + Paclitaxel vs Placebo + Paclitaxel: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02178956

GET https://conductscience.org/api/trials/v1/NCT02178956/events?page=2

API reference For AI assistants