A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

Phase 3

Completed

• Conditions: Cancer of the colon and rectum; metastasized cancer; 10017990

• Registration Number: NL-OMON36541
• Lead Sponsor: Eli Lilly

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients will be at least 18 years of age with metastatic CRC progressive during or following first-line combination therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Patients may have either measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v. 1.1), and must have Eastern Cooperative Oncology Group status of 0 or 1as well as adequate hematologic, coagulation, and organ function.

Exclusion Criteria

Patients must have received no more than 2 prior systemic chemotherapy regimens in any setting and must not have experienced a Grade 3 or higher bleeding event within 3 months prior to randomization, or an arterial thrombotic event within 12 months of randomization. Patients must also not have an uncontrolled intercurrent illness, leptomeningeal disease or brain metastases, or active infection requiring parenteral therapy. Lastly, patients must not have received bevacizumab within 28 days of randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy: Efficacy assessments include imaging studies/tumor assessments,<br /><br>according to RECIST v. 1.1, performed every 6 weeks (±3 days); PRO assessments;<br /><br>serum carcinoembryonic antigen; and survival.<br /><br>Safety: Safety will be evaluated based on recorded adverse events (AEs),<br /><br>physical examinations, vital sign measurements, and clinical laboratory<br /><br>assessments. Adverse events will be coded using the Medical Dictionary for<br /><br>Regulatory Activities (MedDRA*). Adverse events and clinical laboratory values<br /><br>will be graded using the National Cancer Institute Common Terminology Criteria<br /><br>for Adverse Events, Version 4.02 (NCI CTCAE v. 4.02).</p><br>