A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

Summary

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Ivosidenib Oral Tablet

  500mg Ivosidenib taken orally once daily for continuous 28-day cycles

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