Trial Profile

A phase 3 Study of Onvansertib in first-line RAS-mutated mCRC patient

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 12 Nov 2024

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At a glance

07 Nov 2024 According to a Cardiff Oncology media release, Initial data readout from first-line RAS-mutated mCRC randomized CRDF-004 trial expected by the end of 2024.
09 Aug 2023 New trial record
07 Aug 2023 According to a Cardiff Oncology media release, contingent upon the results of CRDF-004, the company will initiate a Phase 3, randomized trial with registrational intent. The FDA has agreed that a seamless trial with objective response rate (ORR) at an interim point is an acceptable endpoint to pursue accelerated approval, with progression-free survival (PFS) and trend in overall survival being the endpoints for full approval.

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