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Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 7 to 9 Eligibility criteria expanded, about 14 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 14 words
  2. Study sites revised (7)v5 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 6 to 7v4
  4. Study sites: 5 to 6v3
  5. Trial sites expanded: 0 → 5 locationsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nuvation Bio
10 trials monitored
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Glioma
668 trials monitored
See 40 trials at risk
This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \[BICR\] per modified Response Assessment in Neuro-Oncology \[RANO\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.
Trial Details
NCT Number NCT07703436
Lead Sponsor Nuvation Bio Inc.
Conditions Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma, Glioma, IDH1-mutant Glioma, Oligodendroglioma, Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted, Astrocytoma IDH Mutant Grade 3, Astrocytoma IDH Mutant Grade 2
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov