NCT07923071Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
A Phase 1, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Relapsed/Refractory Hematologic Malignancies and Severe Hepatic or Renal Impairment or Normal Hepatic and Renal Function
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney impairment or normal liver and kidney function.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- Syndax Pharmaceuticals
- NCT number
- NCT07923071
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From Nov 2026 to the primary completion date, Jan 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gastrointestinal Disease (GI) within previous 6 months.
- Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
Other illness
- Uncontrolled active infection of any type. Infections under control with antibiotic treatment are acceptable for study entry.
- Uncontrolled invasive fungal infection (positive blood or tissue culture).
Lab values
- QT interval corrected for heart rate using Fridericia's formula (QTcF) of \>450 millisecond (ms) (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
- Participants requiring the concurrent use of medications known or suspected to prolong the QT/QTc interval, with the exception of drugs with low risk of QT/QTc prolongation that are used as standard supportive therapies (for example, diphenhydramine, famotidine, ondansetron, Bactrim) and the azoles permitted.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Documented active diagnosis of R/R hematologic malignancy (for example, R/R acute leukemias \[acute myeloblastic leukemia \[AML\]/acute lymphoblastic leukemia \[ALL\] or mixed phenotype acute leukemia \[MPAL\]) in medically stable individuals based on their medical history and clinical evaluation who may benefit from revumenib as determined by the Investigator.
- Hepatic and renal function as indicated by clinical chemistry values.
- Adequate cardiac function defined as ejection fraction ≥50% by echocardiogram or multigated acquisition (MUGA) scan.
- Potassium maintained at ≥4.0 milliequivalent/liter (mEq/L) and magnesium at ≥2.0 milligram/deciliter (mg/dL).
- White blood cell (WBC) must be \< 25,000/microliter (µL) prior to the first dose of revumenib.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2 at Screening. (For participants ≥65 years of age, an ECOG PS score of 0 or 1.)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.