BridgeMD
Tests treatment safety and results for Advanced Malignancies and Hepatic Impairment
Official title Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
ClinicalTrials.gov ID: NCT07422610
What this study is testing
What is pelabresib?
pelabresib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced malignancies and hepatic impairment.
Also referred to as DAK539 (formerly CPI-0610).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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:
- Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment
You likely can't join if
- 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...
- Has esophageal variceal bleeding within the past 2 months prior to the first dose of pelabresib.
- Has an active clinically significant infection.
See the full eligibility 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:
- 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.
- 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:
- 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:
- moderate HI: total bilirubin \>1.5 × to 3 × ULN, and any AST value
- severe HI: total bilirubin \> 3 × ULN, and any AST value Key
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Saint-Herblain, France
- Candiolo, TO, Italy
- Pozuelo de Alarcón, Madrid, Spain
- Barcelona, Spain
- Madrid, Spain
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Saint-Herblain, France; Candiolo, TO, Italy; Pozuelo de Alarcón, Madrid, Spain; Barcelona, Spain; Madrid, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.