This study is currently not recruiting participants.

LCCC1029; Multi-Center Randomized Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI Versus Placebo With FOLFIRI as Second-Line Therapy in Patients With Metastatic Colorectal Cancer

  • STATUS
    Not Recruiting
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Updated on 19 February 2024

Summary

The purpose of this study is to compare progression-free survival between regorafenib + FOLFIRI chemotherapy versus placebo + FOLFIRI in patients with metastatic colorectal carcinoma previously treated with a FOLFOX regimen.

Description

This randomized (2:1 ratio), multi-center, placebo-controlled, phase II efficacy study is designed to compare progression-free survival (PFS) between regorafenib + FOLFIRI (5-fluorouracil + leucovorin + irinotecan [ARM A] versus placebo + FOLFIRI [ARM B]) in patients with metastatic colorectal carcinoma (mCRC) previously treated with a FOLFOX (5-fluorouracil + leucovorin + oxaliplatin) regimen. A pharmacokinetic (PK) evaluation of irinotecan will be conducted in a subset of patients at selected sites. This trial also incorporates a number of exploratory analyses designed to evaluate potential correlations between blood and tissue biomarkers and clinical benefit.

Details
Condition Colorectal Cancer
Age 18years - 100years
Clinical Study IdentifierTX4234
Last Modified on19 February 2024

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