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

Conditions

• IDH1-Mutated Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ivosidenib Oral Tablet — DRUG
  500mg Ivosidenib taken orally once daily for continuous 28-day cycles

Study Details

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.

Key Dates

Start date

Jan 14, 2026

Status verified

May 2026

Primary completion

Jul 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 - Moderate Hepatic Impairment (HI)
• Experimental: Group 2 - Severe HI
• Experimental: Group 3 - Severe Renal Impairment (RI)
• Experimental: Group 4 - Adequate hepatic function
• Experimental: Group 5 - Adequate renal function

Primary Outcome Measure

Maximum observed steady-state concentration (Cmax,ss) [ Time Frame: Through day 28 of cycle 1 ]

Central Contacts

• Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
  +33 1 55 72 60 00
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA

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