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Home » Find Clinical Trials » A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

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

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Servier Protocol Code: S095031-218 Sponsor: Servier Bio-Innovation LLC Clinicaltrials.gov Identifier: NCT07006688 EU Trial (CTIS) Number: 2024-517923-38-00

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Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00

Study description

This study is needed to test a new drug called ivosidenib in participants with cancer and moderate or severe liver problems or severe kidney problems. Specifically, this study involves participants whose cancer has a specific gene change called an IDH1 mutation.

IDH1 mutations lead to abnormal (mutated) form of IDH1 proteins in cancer cells. When these abnormal proteins are present, too much 2-hydroxyglutarate (2-HG) is produced. This disrupts normal cell functioning and may cause cells to become cancer cells.

Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins and lowers 2-HG levels in tumor cells to normal levels. Ivosidenib has already been approved in certain countries for the treatment of patients with different types of cancer with an IDH1 mutation.

The main goal of this study is to see how the body processes ivosidenib in participants with cancer with an IDH1 mutation, and liver or kidney problems.

Official title: 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
Conditions
IDH1-Mutated Malignancies
Interventions / Treatments
  • Ivosidenib Oral Tablet
Other study id numbers
  • S095031-218

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged 18 or older.
  • Have cancer with an IDH1 mutation.
  • Have either moderate or severe liver problems, or severe kidney problems.

Participants cannot take part in the study if they:

  • Have had a bone marrow (spongy tissue inside the bones) transplant within 60 days before receiving the study drug.
  • Have received treatment for cancer with drugs or radiation in the 14 days before receiving the study drug.
  • Have had surgery in the 4 weeks before receiving the study drug.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Group 1 – Moderate Liver Problems
Intervention / Treatment
Drug: Ivosidenib Oral Tablet

Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.

Participant Group / Arm
Experimental: Group 2 - Severe Liver Problems
Intervention / Treatment
Drug: Ivosidenib Oral Tablet

Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.

Participant Group / Arm
Experimental: Group 3 - Severe Kidney Problems
Intervention / Treatment
Drug: Ivosidenib Oral Tablet

Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.

Participant Group / Arm
Experimental: Group 4 – Good liver function
Intervention / Treatment
Drug: Ivosidenib Oral Tablet

Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.

Participant Group / Arm
Experimental: Group 5 – Good kidney function
Intervention / Treatment
Drug: Ivosidenib Oral Tablet

Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.