Pacylex Pharmaceuticals
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.
This is a dose-finding study of oral PCLX-001 in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion. Dose Escalation will determine the minimum safe and biologically-effective dose of daily oral PCLX-001 in patients with R/R AML. The Bayesian optimal interval (BOIN) design will be used for dose escalation, informed by real-time assessment of safety, efficacy, PK and PD in each dose cohort. A maximum of 15 patients will enroll in the dose escalation part. Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle. The starting dose will…
Inclusion Criteria: \- The following inclusion criteria apply to ALL (dose escalation and dose expansion) patients: 1. 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. 2. Male or female patients aged ≥ 18 years 3. A diagnosis of AML as per 2016 WHO classification (Arber et al, 2016) 4. Patients must have received at least one prior therapy for AML 5. Patient must not be eligible for other therapies expected to provide clinical benefit 6. Eastern Cooperative Oncology Gr…
Zelenirstat will be administered orally, once daily, on 28-day cycles, at the same time each day.
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