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

Eli Lilly Japan K.K.0 个研究点开始时间: 2011年2月10日最近更新: 2023年10月17日

试验速览

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•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.

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