A Phase 1b, Open-Label, Multicenter Study to Evaluate the Pharmacokinetic Profile of Pelabresib (DAK539/CPI-0610) in Patients With Advanced Malignancies and Hepatic Impairment

Study Identifier:
CDAK539A12103
CT.gov Identifier:
NCT07422610
EudraCT Identifier:
202552100140
EU Trial (CTIS) Number:
2025-521001-40-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Other
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18 - 75 Years
Study Drug
Drug: EXPERIMENTAL: Group 1 (normal hepatic function)
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Drug: Part 1: Participants receive pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break (1 cycle = 21 days).
Drug: If clinical benefit is observed, treatment continues in Part 2 until end of study (EOS), discontinuation criteria, or alternative access.
Drug: Drug: pelabresib
Drug: pelabresib 125 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break
Drug: Other Names: DAK539 (formerly CPI-0610)
Drug: EXPERIMENTAL: Group 2 (moderate or severe HI)
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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 <5% if the assessment is performed.
  • * Has a life expectancy ≥3 months.
  • * Has fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy .
  • * Hepatic function:
  • 1. 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
  • 2. Is in Group 2 and has stable moderate or severe HI as defined by NCI ODWG criteria:
  • * moderate HI: total bilirubin >1.5 × to 3 × ULN, and any AST value
  • * severe HI: total bilirubin > 3 × ULN, and any AST value
  • Key
Exclusion criteria
  • Has a history of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical class.
  • * Has any other medical condition which, in the investigator's opinion, makes the participant unsuitable for the study.
  • * Is a female participant who is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding.
  • * Is a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 184 days after the last dose of study treatment, and who does not agree to refrain from donating eggs during this period.
  • * Has esophageal variceal bleeding within the past 2 months prior to the first dose of pelabresib.
  • * Has an active clinically significant infection.
  • * Has impaired cardiac function or clinically significant cardiac diseases
  • * Has a GI tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the GI tract that could alter the absorption of pelabresib, including any unresolved nausea, vomiting, or diarrhea.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Will Be Recruiting
Condition(s) Treated at Site
Other
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Manuel Pedregal Trujillo
Status
Will Be Recruiting
Condition(s) Treated at Site
Other