RecruitingPhase 1

Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment

France, Italy, Spain24 participantsStarted 2026-04-24

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment
. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors
. Adequate renal function (creatinine clearance of ≥30 mL/min, calculated using Cockcroft-Gault formula)
. Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening, however, blasts must be \<5% if the assessment is performed.
. Is in Group 1 and is classified as having normal hepatic function based on NCI-ODWG criteria (i.e., total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ ULN); or
. Is in Group 2 and has stable moderate or severe HI as defined by NCI ODWG criteria:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Curve from 0 to 24 hours on Day 14 (AUC₀-24h,D14) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)

Maximum Plasma Concentration on Day 14 (Cmax,D14) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Apparent Clearance (CL/F) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Apparent Volume of Distribution (V/F) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Terminal Half-Life (T½) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Trial details

NCT IDNCT07422610

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-28

Contact for this trial

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

View on ClinicalTrials.gov More Advanced Malignancies and Hepatic Impairment trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment
. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors
. Adequate renal function (creatinine clearance of ≥30 mL/min, calculated using Cockcroft-Gault formula)
. Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening, however, blasts must be \<5% if the assessment is performed.
. Is in Group 1 and is classified as having normal hepatic function based on NCI-ODWG criteria (i.e., total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ ULN); or
. Is in Group 2 and has stable moderate or severe HI as defined by NCI ODWG criteria:

What they're measuring

Area Under the Curve from 0 to 24 hours on Day 14 (AUC₀-24h,D14) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14: 0, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose (1 cycle = 21 days)

Maximum Plasma Concentration on Day 14 (Cmax,D14) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Apparent Clearance (CL/F) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Apparent Volume of Distribution (V/F) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)

Terminal Half-Life (T½) of pelabresib at steady state per study group

Timeframe: Cycle 1 Day 14 (1 cycle = 21 days)