BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma
Phase 3
- Conditions
- Colorectal Carcinoma
- Registration Number
- JPRN-jRCT2080222249
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
- Histologically confirmed advanced colorectal cancer that is unresectable.
- The only remaining standard available therapy as recommended by the Investigator is best supportive care.
- Must have presence of measurable disease as defined by RECIST 1.1.
- Must have an ECOG Performance Status of 0 or 1.
etc.
Exclusion Criteria
- 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>OS
- Secondary Outcome Measures
Name Time Method - Efficacy <br>- Safety<br><br>PFS, DCR, AE, QO