Colorectal Carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : Ramucirumab (IMC-1121B)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investiga
every 2 weeks
Generic name etc : levofolinate
INN of investigational material :
Therapeutic category code : 392 Antidotes
Dosage and Administration for Investigational material : IV infusion, 200 mg/
every 2 weeks
Generic name etc : 5-FU
INN of investigational material :
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 400 mg/m²
bolus followed by a 2400 mg/m²
continuous infusion, every 2 weeks
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Outcome results
None listed