A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer (BRIGHTER)
Phase 3
Completed
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Registration Number
- JPRN-jRCT2080222639
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
- Cytologically or histologically confirmed advanced gastric or GEJ adenocarcinoma that is metastatic or locally advanced and unresectable.
- Failed treatment with one regimen containing at least a platinum/fluoropyrimidine doublet for unresectable or metastatic disease.
- ECOG performance status of 0 or 1
etc.
Exclusion Criteria
- Prior taxanes in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxanes in the metastatic setting.
- Major surgery within 4 weeks prior to randomization.
- Any known symptomatic brain metastases requiring steroids.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>OS
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>confirmatory<br>PFS, DCR, AE, QO