CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 714 enrolled
Drug / intervention
BBI608 +2 moredrug
Likely dose
BBI608 480 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02178956
NCT02178956Phase 3Completed
CompareCT.gov

A Phase III Clinical Trial of BBI608 Plus Weekly Paclitaxel vs. Placebo Plus Weekly Paclitaxel in Adult Patients With Advanced, Previously Treated Gastric and Gastro-Esophageal Junction Adenocarcinoma

Sumitomo Pharma America, Inc.·interventional·Posted Jul 1, 2014·Updated Nov 15, 2023

In Brief

A Phase 3 clinical trial evaluating BBI608, Paclitaxel, and 1 other intervention for Gastric Cancer and Gastroesophageal Junction Cancer. Completed, enrolled 714 participants across 263 sites in 22 countries.

Detailed Summary

The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Gastroesophageal Junction Cancer
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Lithuania, Poland, Romania, Russia, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 1, 2014
Enrollment StartOct 1, 2014
Primary CompletionSep 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.0 years ago

Interventions

BBI608drug

BBI608 480 mg orally two times daily (960 mg total daily dose)

Paclitaxeldrug

Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle

Placeboother

Orally two times daily