ClinicaliQ Trial Snapshot
- Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment — Recruiting • Phase I • Oncology • NCT07422610.
- What is being tested: Pelabresib pharmacokinetics and safety in patients with advanced malignancies, specifically comparing drug exposure and clearance between those with hepatic impairment and normal liver function to determine if dose adjustments are needed.
- Patient eligibility overview: Adults with confirmed advanced malignancies stratified by hepatic function status (normal, mild, moderate, or severe impairment), allowing evaluation across a spectrum of liver dysfunction relevant to oncology populations.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free washout periods.
Eligibility Snapshot
- Key Inclusion Criteria: * Is at least 18 and not older than 75 years of age at the time of signing the informed consent. * Group 1 only: There is a matching participant in Group 2 and an enrollment slot is available for the Group 1 participant. * Has a confirmed documented diagnosis of an advanced malignancy for which no standard and/or curative treatment options are available. * Has the following acceptable laboratory assessments prior to the first dose of study treatment: 1. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment 2. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors 3. Adequate renal function (creatinine clearance of ≥30 mL/min, calculated using Cockcroft-Gault formula) 4. Peripheral blood blast count < 5%. Assessment of blasts in bone marrow is not mandatory at screening, however, blasts must be 1.5 × to 3 × ULN, and any AST value * severe HI: total bilirubin > 3 × ULN, and any AST value Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.