A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
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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.
- Ivosidenib Oral Tablet
- S095031-218
Eligibility Criteria
Eligible age for the study
Sexes
Male/FemaleAccepts Healthy Volunteers
NoTo 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?
Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.
Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.
Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.
Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.
Participants take 500 mg Ivosidenib orally once daily for 28-day cycles.