Study of Radiolabeled SNDX-5613 in Adults With Acute Myeloid Leukemia

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open-label study to study the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-SNDX-5613 in adult males with acute myeloid leukemia (AML).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syndax Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Males aged 18 and older.

• Active AML

• Recurrent or refractory AML after 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

• Isolated extramedullary relapse

• White blood cell (WBC) count >25,000/microliters at time of enrollment.

• Active central nervous system (CNS) disease (cytologic or radiographic).

• Detectable human immunodeficiency virus viral load within the previous 6 months

• Hepatitis B or Hepatitis C

• Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)

• Concurrent malignancy in the previous 2 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, low-grade lymphoma that does not require treatment, or carcinoma in situ treated with potentially curative therapy

• 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 SNDX-5613 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 SNDX-5613

• Any concurrent systemic treatment to prevent GVHD