A Study of Ivosidenib for IDH1-Mutated Cancers with Liver or Kidney Problems
This study is testing a drug called ivosidenib oral tablet in adults with cancers that have a specific genetic change (IDH1-mutated malignancies). This includes various blood cancers and solid tumors. The study is for people who also have liver or kidney problems. Researchers want to understand how the body handles ivosidenib (pharmacokinetics), its effects (pharmacodynamics), and its safety and side effects. You would take 500mg of ivosidenib by mouth once daily in continuous 28-day cycles. The study will measure how much drug is in your blood at different times to understand how it works in people with liver or kidney issues. The current status of the study is unclear, and it plans to enroll about 30 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll approximately 30 participants into one of five groups based on their liver or kidney function.
- What's involved
- You would have study visits on specific days during each 28-day cycle, including blood tests, ECGs (heart rhythm checks), vital signs, and physical exams. Treatment cycles will continue until the end of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Approximately 30 days after your treatment ends, there will be a safety follow-up visit.
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NCT07006688
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
Recruiting
PHASE1Ages 18+InterventionalTreatmentServier Bio-Innovation LLC
~30 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Ivosidenib Oral Tablet
At a glance
Recruiting sites
17 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum observed steady-state concentration (Cmax,ss)
Measured over Through day 28 of cycle 1
+3 more outcomes measured
Conditions
Where it's being run
20 sites across 12 statesSpain5
Czechia3
South Korea3
Georgia1
Ohio1
Texas1
Queensland1
South Australia1
Who to contact
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants with hematologic malignancies (including but not limited to acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms, clonal cytopenia of unknown significance with a high-risk score \[CHRS ≥12.5\], chronic myelomonocytic leukemia, multiple myeloma, and non-Hodgkin's lymphoma) or solid tumors excluding glioma, with a locally confirmed IDH1 R132 mutation before Cycle 1 Day 1.
Based on renal and hepatic function, participants within the:
Participants of the control groups with adequate hepatic or renal function characterized as:
Participants previously or currently treated with ivosidenib are eligible if treated at the 500 mg QD dose or if treated at the 250 mg QD dose due to strong cytochrome P450 (CYP)3A4 inhibitor intake. Participants with a hematologic malignancy on co-treatment with azacitidine are also eligible.
WOCBP must agree to abstain from sexual intercourse or use 2 effective methods of birth control (a highly effective method and a barrier method) from the time of giving informed consent throughout the study and for 90 days after the last dose of ivosidenib. Hormonal contraception alone is not considered an acceptable method of contraception and should be combined with a barrier method.
Exclusion
Have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of ivosidenib, or on immunosuppressive therapy post-HSCT at the time of screening, or with active acute or chronic graft-versus-host-disease (GVHD) requiring systemic therapy. (Participants with GVHD managed by minimal interventions \[a physiologic dose of steroids\] are permitted with the medical monitor's approval.)
Have received systemic anticancer therapy (with the exception of azacitidine), investigational agent treatment, or radiotherapy \<14 days, or had surgery \<4 weeks before planned Cycle 1 Day 1 of ivosidenib, and/or did not recover from the AEs associated with these therapies and/or surgeries. In addition, the first dose of ivosidenib should not occur before a period of ≥5 half-lives of the study drug has elapsed.
Have hematological diseases (other than AML or MDS) or solid tumors that are eligible for other treatments known to provide clinical benefit.
Have received calcineurin inhibitors within 4 weeks prior to enrollment.
Have significant active cardiac disease within 6 months before the start of ivosidenib, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
Use of any medications that are known to prolong the QT interval unless they can be transferred to other medications within ≥5 half-lives before dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTcF should be closely monitored).
Planned use of any strong CYP3A4 inducer or sensitive CYP3A4 substrate with a narrow therapeutic window or certain antifungals that are CYP3A4 substrates while the participant is receiving ivosidenib. Participants who are taking these medications must have the minimum washout period of ≥5 half-lives before the first dose of ivosidenib and not take the medications for the duration of their participation in the study.
Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or laparoscopic gastric banding, short-gut syndrome, gastroparesis, or other active conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).
Have a known familial history of sudden death or polymorphic ventricular arrhythmia.
What this trial measures
- Maximum observed steady-state concentration (Cmax,ss)Through day 28 of cycle 1
- Area under the concentration time curve from 0 to 24 hours (AUC0-24hr)Through day 28 of cycle 1
- Predose plasma concentration (Ctrough)Through day 28 of cycle 1
- Time to maximum observed concentration (Tmax)Through day 28 of cycle 1