Actively Recruiting
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Led by Novartis Pharmaceuticals · Updated on 2026-05-11
24
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at informed consent signing
- For Group 1 participants: must have a matching participant in Group 2 and an available enrollment slot
- Confirmed diagnosis of advanced malignancy with no standard or curative treatment options
- Platelet count at least 150 x 10^9/L without recent transfusions or thrombopoietic factors
- Absolute neutrophil count at least 1 x 10^9/L without growth factors
- Adequate kidney function with creatinine clearance of at least 30 mL/min
- Peripheral blood blast count less than 5%; bone marrow blasts must be less than 5% if assessed
- Life expectancy of at least 3 months
- Fully recovered from major surgery and acute toxic effects of prior chemotherapy and radiotherapy
- Group 1: Normal liver function based on NCI-ODWG criteria
- Group 2: Stable moderate or severe hepatic impairment per NCI-ODWG criteria
You will not qualify if you...
- History of hypersensitivity to pelabresib, its components, or similar drugs
- Any medical condition making participation unsuitable per investigator
- Pregnant or breastfeeding women
- Women of childbearing potential not following contraceptive guidance during and 184 days after treatment and not agreeing to not donate eggs
- Esophageal variceal bleeding within 2 months before first pelabresib dose
- Active clinically significant infection
- Impaired cardiac function or clinically significant cardiac diseases
- Gastrointestinal tumors, impaired GI function, GI disease, or significant GI surgery affecting pelabresib absorption, including unresolved nausea, vomiting, or diarrhea
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Novartis Investigative Site
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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