Actively Recruiting
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
Led by Pacylex Pharmaceuticals · Updated on 2025-03-10
35
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
P
Pacylex Pharmaceuticals
Lead Sponsor
O
Ozmosis Research Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign written informed consent before any study procedures
- Male or female patients aged 18 years or older
- Diagnosis of AML according to 2016 WHO classification
- Received at least one prior AML therapy
- Not eligible for other therapies expected to provide clinical benefit
- ECOG performance status of 0, 1, or 2
- No use of chemotherapeutic or anti-leukemic agents during study except intrathecal therapy for controlled CNS leukemia and hydroxyurea for rapidly proliferative disease before and during first 4 weeks of therapy
- Adequate liver function: total bilirubin ≤1.5 times ULN (unless due to hemolysis or congenital disorder), ALT and AST ≤2.5 times ULN or ≤5 times ULN for malignant liver involvement
- Adequate kidney function: eGFR >60 mL/min and creatinine ≤1.5 times ULN within 7 days before first dose
- Adequate cardiac function with LVEF ≥50% by echocardiography or MUGA scan
- Ability to take oral medication
- Women of childbearing potential must have negative pregnancy test within 7 days before starting study drug
- Women of childbearing potential and fertile men must agree to use two reliable contraception methods from consent signing until 6 months after last drug administration
- Male patients with female partners of reproductive potential must use condoms and an additional contraception method during treatment and for 6 months after last drug administration
You will not qualify if you...
- Acute promyelocytic leukemia
- Known allergy to the study drug, its ingredients, or any agent used in the study
- History of severe cardiac disease including congestive heart failure NYHA class > II, unstable or recent angina, recent myocardial infarction, or uncontrolled arrhythmias
- Uncontrolled high blood pressure despite treatment
- Moderate or severe liver impairment (Child-Pugh class B or C)
- Uncontrolled HIV infection
- Active hepatitis B or C infection requiring treatment
- Infections grade 2 or higher not responding to therapy or serious infections grade above 2
- Uncontrolled seizure disorder treated with strong CYP3A4 inducers
- Previous or current cancer distinct from AML except certain localized or low-risk cancers
- Inability to swallow oral medication
- Conditions causing poor absorption of the study drug
- Breastfeeding or planning to breastfeed during and up to 4 months after last drug dose
- Unstable or significant toxic effects from prior chemotherapy or immunotherapy
- Receiving active radiation or anti-cancer therapy for another cancer during screening
- Previous participation in this study
- Concurrent participation in another clinical trial with investigational drugs
- Substance abuse or medical, psychological, or social conditions interfering with study participation
- ECG abnormalities such as significant heart block, prolonged QRS complex, or prolonged QTc interval unless approved by investigator and sponsor
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Centre
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Pacylex Pharmaceuticals
CONTACT
H
Heit, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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