Phase Ib study of FOLFOXIRI plus ramucirumab as first-line treatment in patients with metastatic colorectal cancer
Phase 1
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000023277
- Lead Sponsor
- Pharma Valley Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Not provided
Exclusion Criteria
1. Serious complications (e.g. other active co-existing malignancies, brain metastases, and malignant coelomic fluid required drainage) 2. Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks. 3. Grade >=2 peripheral neuropathy 4. Administration of blood transfusion or G-CSF within 2 weeks 5. Thromboembolism (grade 3 or higher) within 6 months 6. Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity in the first cycle
- Secondary Outcome Measures
Name Time Method Objective response rate, progression-free survival (PFS), PFS2, time to treatment failure, overall survival, and safety