NCT05406817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

June 1, 2022

Last Update Submit

January 8, 2025

Conditions

Acute Leukemia

Keywords

SNDX-5613Acute LeukemiaRefractory leukemiaRelapsed leukemia

Outcome Measures

Primary Outcomes (6)

  • Percentage of Dose Excreted in Urine (feu)

    Up to Day 11

  • Percentage of Dose Excreted in Feces (fef)

    Up to Day 11

  • Amount Excreted in Urine (Aeu)

    Up to Day 11

  • 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

  • Maximum Observed Concentration (Cmax)

    Up to Day 21

Secondary Outcomes (1)

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    up to approximately 1 year

Study Arms (1)

Revumenib

EXPERIMENTAL

Participants will be administered a single dose of revumenib (containing \~100 microcuries \[14C\]-revumenib) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled revumenib. revumenib 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: Revumenib

Interventions

RevumenibDRUG

Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.

Also known as: SNDX-5613
Revumenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

revumenib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Nicole McNeer, MD, PhD

    Syndax Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 7, 2022

Study Start

August 5, 2022

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)