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A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Glioma

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Trial Profile

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Glioma

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Safusidenib (Primary)
  • Indications Astrocytoma; Glioma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms G203
  • Sponsors AnHeart Therapeutics; Nuvation Bio

Most Recent Events

  • 30 May 2025 Protocol amended with indication 'astrocytoma'. Open label arm cancelled. Primary endpoint ORR replaced with PFS. Arms increased from 5 to 7.
  • 30 May 2025 Planned number of patients changed from 95 to 125.
  • 30 May 2025 Planned End Date changed from 31 Jul 2027 to 1 Mar 2028.

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