A phase I study of irinotecan, bevacizumab and biweekly TAS-102 in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidine and oxaliplati
Phase 1
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000019828
- Lead Sponsor
- Pharma Valley Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
1) Serious illness such as brain metastasis, systemic infection or gastrointestinal bleeding. 2) Medical treatment such as major surgery within 4 weeks, systemic chemotherapy within 2 weeks. 3) Adverse events due to prior chemotherapy 4) Administration of blood transfusion or G-CSF within 2 weeks 5) Severe pulmonaly disorder 6) Thromboembolism (grade3 or higher) within 6 months 7) Inappropriate for the study in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part1(dose-escalation): DLT between first 2 cycles Part2(expansion): the incidence of febrile neutropenia
- Secondary Outcome Measures
Name Time Method Progression free survival Time to treatment failure Overall survival Objective response rate Disease control rate Safety