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New treatment option for IDH1-Mutated Malignancies
Official title A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
ClinicalTrials.gov ID: NCT07006688
What this study is testing
What is Ivosidenib Oral Tablet?
Ivosidenib Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for idh1-mutated malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with hematologic malignancies (including but not limited to acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)...
- Based on renal and hepatic function, participants within the: a. Moderate HI group, must have: i. Total bilirubin \>1.5 to 3 × upper limit of normal...
- Blood total bilirubin ≤1.5 × ULN, unless due to Gilbert's disease, where participants should have blood total bilirubin ≤3 × ULN;
- AST, alanine aminotransferase, and alkaline phosphatase ≤3.0 × ULN
- Participants of the control groups with adequate hepatic or renal function characterized as:
You likely can't join if
- Have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of ivosidenib, or on immunosuppressive therapy post-HSCT at...
- Have received systemic anticancer therapy (with the exception of azacitidine), investigational agent treatment, or radiotherapy \<14 days, or had...
- 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...
- 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...
See the full eligibility criteria
- 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...
- Based on renal and hepatic function, participants within the: a. Moderate HI group, must have: i. Total bilirubin \>1.5 to 3 × upper limit of normal (ULN), not linked to Gilbert's disease, and any aspartate...
- Blood total bilirubin ≤1.5 × ULN, unless due to Gilbert's disease, where participants should have blood total bilirubin ≤3 × ULN;
- AST, alanine aminotransferase, and alkaline phosphatase ≤3.0 × ULN
- Participants of the control groups with adequate hepatic or renal function characterized as:
- Hepatic control group: Adequate hepatic function as evidenced by total bilirubin and AST ≤ULN, and normal to mild RI (CrCl ≥60 mL/min estimated according to the Cockcroft-Gault formula).
- Renal control group: Adequate renal function as evidenced by CrCl ≥90 mL/min (estimated according to the Cockcroft-Gault formula) and normal to mild HI (total bilirubin ≤1.5 × ULN, participants with Gilbert's disease...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Have a known familial history of sudden death or polymorphic ventricular arrhythmia.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Houston, Texas, United States
- South Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, Brazil
- Prague, HlavnÃ- Mesto Praha, Czechia
- Brno, Czechia
- Ostrava, Czechia
- Prague, Czechia
- Seongnam-si, Gyeonggi-do, South Korea
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Houston, Texas, United States; South Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; São José do Rio Preto, São Paulo, Brazil; São Paulo, Brazil and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.