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
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
Treatments tested in this trial
- zelenirstat
Treatment groups
35 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Pacylex Pharmaceuticals
Lead sponsor
Ozmosis Research Inc.
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov