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Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia

NCT06613217 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-03-10

No results posted yet for this study

Summary

This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.

Conditions

  • Relapsed Adult AML

Interventions

DRUG

zelenirstat

Zelenirstat will be administered orally, once daily, on 28-day cycles, at the same time each day.

Sponsors & Collaborators

  • Ozmosis Research Inc.

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • Pacylex Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Naveen Pemmaraju · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-03-01
Completion
2026-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06613217 on ClinicalTrials.gov