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

Part of paid clinical trials in Houston, Texas.

Sponsor
Pacylex Pharmaceuticals
Study ID
NCT06613217
Phase
PHASE1
Status
Recruiting
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Conditions

  • Relapsed Adult AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Mar 2025
Primary completion
Mar 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: zelenirstat intervention in R/R AML at 40mg daily
    Three patients will be treated at 40 mg daily dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level.
  • Experimental: zelenirstat intervention in R/R AML at 70mg daily
    Three patients will be treated at 70 mg daily dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level.
  • Experimental: zelenirstat intervention in R/R AML at 100mg daily
    Three patients will be treated at 100 mg daily dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level.
  • Experimental: zelenirstat intervention in R/R AML at 140mg daily
    Three patients will be treated at 140 mg each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level.
  • Experimental: zelenirstat intervention in R/R AML at 210mg daily (if needed)
    Three patients will be treated at 210 mg daily dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level.
  • Experimental: zelenirstat intervention in R/R AML at 280mg daily (if needed)
    Three patients will be treated at 280 mg daily dose level. If 0/3 patients experience DLT, 3 additional patients will be treated at the same dose and the study will be concluded.

Primary Outcome Measure

To determine, during the dose escalation phase, the recommended dose of zelenirstat for the dose expansion phase of the trial. [ Time Frame: Up to 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CentreHoustonTexas77030
Naveen Pemmaraju
[email protected]
713-792-4956

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By research site
MD Anderson Cancer Centre· Houston, TX

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