A Phase 1b Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B) Drug Product in Japanese Subjects With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
- Conditions
- Colorectal Carcinoma
- Registration Number
- JPRN-jRCT2080221386
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:
Participant is Japanese.
Has an ECOG performance status of 0 or 1.
Has histologically or cytologically confirmed CRC
Has metastatic disease that is not amenable to potentially curative resection.
Has measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
Has received no more than 2 prior systemic chemotherapy regimens in any setting.
Has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and has experienced disease progression during first-line therapy, or disease progression within 6 months after the last dose of first-line therapy.
Has adequate hepatic, renal, hematologic, and coagulation function
Eligible participants of reproductive potential agree to use adequate contraceptive methods during the study period and for 12 weeks after the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method