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A Phase 3, pivotal, randomized trial of Onvansertib

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Trial Profile

A Phase 3, pivotal, randomized trial of Onvansertib

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2023

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At a glance

  • Drugs Onvansertib (Primary)
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 02 Nov 2023 According to a Cardiff Oncology media release, 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 and trend in overall survival being the endpoints for full approval.
  • 20 Aug 2023 New trial record
  • 09 Aug 2023 According to a Cardiff Oncology media release, contingent upon the results of CRDF-004, Cardiff Oncology will initiate CRDF-005, a Phase 3, randomized trial with registrational intent.

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