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

Syndax Pharmaceuticals (Industry)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1

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 SNDX-5613 may remain on study until progressive disease (PD) or unacceptable toxicity.

Study Design

Study Type:
Anticipated Enrollment :
8 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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 Myeloid Leukemia
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SNDX-5613

Participants will be administered a single dose of SNDX-5613 (containing ~100 microcuries [14C]-SNDX-5613) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled SNDX-5613. SNDX-5613 may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity.

Drug: SNDX-5613
Initial radiolabeled SNDX-5613 will be administered as an oral solution. Capsules will be administered thereafter.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Dose Excreted in Urine (feu) [Up to Day 11]

  2. Percentage of Dose Excreted in Feces (fef) [Up to Day 11]

  3. Amount Excreted in Urine (Aeu) [Up to Day 11]

  4. Amount Excreted in Feces (Aef) [Up to Day 11]

  5. Area Under The Curve from Time 0 to The Last Measurable Concentration (AUC0-t) [Up to Day 21]

  6. Maximum Observed Concentration (Cmax) [Up to Day 21]

Secondary Outcome Measures

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [up to approximately 1 year]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • Syndax Pharmaceuticals


  • Study Director: Kate Madigan, M.D., Syndax Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Syndax Pharmaceuticals Identifier:
Other Study ID Numbers:
  • SNDX-5613-0705
First Posted:
Jun 7, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Syndax Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022