Acute Leukemia
Conditions
Keywords
SNDX-5613, Acute Leukemia, Refractory leukemia, Relapsed leukemia
Brief summary
This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 (\[14C\])-revumenib in participants with acute leukemia.
Detailed description
Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.
Interventions
DRUGRevumenib
Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.
Sponsors
Syndax Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Males and females (of non-childbearing potential) aged ≥18 years * Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease. * Previously received standard of care therapy * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Adequate liver and cardiac function * Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose Key
Exclusion criteria
* Active diagnosis of acute promyelocytic leukemia * White blood cell (WBC) count \>25,000/microliters at time of enrollment. * Detectable human immunodeficiency virus viral load within the previous 6 months * Hepatitis B or Hepatitis C * Cardiac, gastrointestinal, or graft-versus-host disease (GVHD) * History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate * Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers * Any commercially available or investigational antileukemic therapy other than revumenib except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction * Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib * Any concurrent systemic treatment to prevent GVHD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount Excreted in Urine (Aeu) | Up to Day 11 |
| Percentage of Dose Excreted in Urine (feu) | Up to Day 11 |
| Percentage of Dose Excreted in Feces (fef) | Up to Day 11 |
| Maximum Observed Concentration (Cmax) | Up to Day 21 |
| Amount Excreted in Feces (Aef) | Up to Day 11 |
| Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t) | Up to Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | up to approximately 1 year |
Countries
United States
Outcome results
None listed