Trials / Completed
CompletedNCT02178956
A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 714 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The goal of this study is to determine if paclitaxel given together with BBI608 as second line therapy will prolong overall survival compared to paclitaxel alone. Approximately 700 patients will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Patients must have failed first line therapy with any platinum/fluoropyrimidine doublet. BBI608/placebo will be administered daily, paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BBI608 | BBI608 480 mg orally two times daily (960 mg total daily dose) |
| DRUG | Paclitaxel | Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle |
| OTHER | Placebo | Orally two times daily |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2017-09-20
- Completion
- 2017-09-20
- First posted
- 2014-07-01
- Last updated
- 2023-11-15
- Results posted
- 2021-05-10
Locations
263 sites across 22 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Lithuania, Poland, Romania, Russia, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02178956. Inclusion in this directory is not an endorsement.