Last updated on February 2020

Phase 1b/2 Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer

Brief description of study

Comparing the efficacy of rivoceranib and trifluridine/tipiracil administered individually as monotherapies, as well as a rivocernib plus trifluridine/tipiracil combination therapy in the treatment of mCRC that is unresponsive to traditional chemotherapies.

Detailed Study Description

This a multicenter open-label study comparing safety, tolerability and efficacy of rivoceranib monotherapy, trifluridine/tipiracil monotherapy and the combination of rivoceranib plus trifluridine/tipiracil in subjects with mCRC. Subjects with histologically or cytologically definitive adenocarcinoma of the colon or rectum who have progressed following standard of care therapy for colorectal cancer will be randomly assigned (1:1:2) to rivoceranib, trifluridine/tipiracil or rivoceranib plus trifluridine/tipiracil treatment groups.

The study will consist of an initial phase 1b portion to assess the safety of and determine the RP2D of rivoceranib in combination with trifluridine/tipiracil. A subsequent phase 2 portion will assess the primary endpoint of PFS by investigator assessment.

Clinical Study Identifier: NCT04073615

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Florida Cancer Specialists

Sarasota, FL United States
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Recruitment Status: Open

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