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

ConditionRelapsed Adult AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPacylex Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained before any study-specific procedures are performed.

Male or female patients aged ≥ 18 years

A diagnosis of AML as per 2016 WHO classification (Arber et al, 2016)

Patients must have received at least one prior therapy for AML

Disqualifiers

Acute promyelocytic leukemia.

Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study

History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class > II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or uncontrolled cardiac arrhythmias

Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)

Trial design

Design model

Sequential

Treatments tested in this trial

  • zelenirstat

    Drug

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

Treatment groups

35 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: zelenirstat intervention in R/R AML at 40mg dailyExperimental treatment 1 intervention
Group B: zelenirstat intervention in R/R AML at 70mg dailyExperimental treatment 1 intervention
Group C: zelenirstat intervention in R/R AML at 100mg dailyExperimental treatment 1 intervention
Group D: zelenirstat intervention in R/R AML at 140mg dailyExperimental treatment 1 intervention
Group E: zelenirstat intervention in R/R AML at 210mg daily (if needed)Experimental treatment 1 intervention
Group F: zelenirstat intervention in R/R AML at 280mg daily (if needed)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To determine, during the dose escalation phase, the recommended dose of zelenirstat for the dose expansion phase of the trial.

The recommended dose will be the dose level below that for the cohort in which maximum tolerated dose (MTD) was reached/exceeded. MTD will have been reached when 2 or more patients in a cohort experience DLT.

Time frame
Up to 18 months

Secondary outcomes

1

To evaluate the clinical response rate in patients treated with zelenirstat with AML.

Tumor response and progression of AML will be evaluated by the investigator at each study center.

Time frame
Up to 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pacylex Pharmaceuticals

Lead sponsor

Ozmosis Research Inc.

Collaborator

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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