Not Yet RecruitingPhase 1

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

24 participantsStarted 2026-05-18

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 range18 Years – 75 Years

SexALL

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)

Trial details

NCT IDNCT07422610

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

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

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

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)