Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Acute Leukemia Clinical Trial

Official title:

A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406817
• Other study ID #: SNDX-5613-0705
• Status: Recruiting
• Phase: Phase 1
• Start date: August 5, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Syndax Pharmaceuticals
• Contact: Syndax Pharmaceuticals
• Phone: 781-419-1400
• Email: clinicaltrials[@]syndax.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Drug:
• Revumenib
Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Syndax Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Dose Excreted in Urine (feu)		Up to Day 11
Primary	Percentage of Dose Excreted in Feces (fef)		Up to Day 11
Primary	Amount Excreted in Urine (Aeu)		Up to Day 11
Primary	Amount Excreted in Feces (Aef)		Up to Day 11
Primary	Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)		Up to Day 21
Primary	Maximum Observed Concentration (Cmax)		Up to Day 21
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		up to approximately 1 year