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A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 19 to 20v8
  2. Site details revised at 1 of 19 sitesv7
  3. Study sites: 18 to 19v6
  4. Site details revised at 3 of 18 sitesv5
  5. Study sites: 11 to 18v4
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  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 8 to 11 · Start date changed from estimate of Jan 2026 to Jan 14, 2026v3 Show 2 more changesShow less
    • Study sites: 8 to 11
    • Start date changed from estimate of Jan 2026 to Jan 14, 2026
  2. Start date: Sep 2025 to Jan 2026 Study sites: 0 to 8 · Primary completion date: Jul 2028 to Jul 31, 2028 · Completion date: Jul 2028 to Aug 31, 2028v2 Show 3 more changesShow less
    • Study sites: 0 to 8
    • Primary completion date: Jul 2028 to Jul 31, 2028
    • Completion date: Jul 2028 to Aug 31, 2028
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.
Trial Details
NCT Number NCT07006688
Lead Sponsor Servier Bio-Innovation LLC
Collaborators: Institut de Recherches Internationales Servier
Conditions IDH1-Mutated Malignancies
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov