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New treatment option for Advanced Malignancies
Official title A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT07340190
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.
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
- This drug-drug interaction (DDI) study aims to evaluate the impact of pelabresib at steady-state plasma concentrations on the pharmacokinetic (PK) profile of A) a single dose of repaglinide and a single dose of midazolam, and B) a single dose of combined drospirenone and ethinyl estradiol. The study will be conducted in adult participants with advanced malignancies for whom no standard or curative treatment options are available.
- 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 and older
You may be able to join if
- Key Key for all participants (Arm A and Arm B)
- Is at least 18 years of age at the time of signing the informed consent.
- 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
- Key exclusion criteria for Arm A
- Has a history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class.
- Is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding.
- Has current known active or chronic infection with HIV, hepatitis B, or hepatitis C.
- Has impaired cardiac function or clinically significant cardiac disease.
- Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract...
See the full eligibility criteria
- Key Key for all participants (Arm A and Arm B)
- Is at least 18 years of age at the time of signing the informed consent.
- 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
- Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening; however, blasts must be \<5% if the bone marrow assessment is performed.
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤5 × ULN if the elevation can be ascribed to liver involvement)
- Calculated or measured creatinine clearance of ≥30 mL/min\
- Has fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual Grade 1 toxicities and residual alopecia of any grade are allowed). Additional inclusion criterion...
- Is a female participant. Key
- Key exclusion criteria for Arm A
- Has a history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class.
- Is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding.
- Has current known active or chronic infection with HIV, hepatitis B, or hepatitis C.
- Has impaired cardiac function or clinically significant cardiac disease.
- Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract that could alter the absorption of pelabresib, midazolam, or...
- Has renal impairment (CrCl less than 50 mL/min).
- Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract that could alter the absorption of pelabresib, drospirenone and ethinyl...
- Has breast cancer or other estrogen- or progestin-sensitive cancer.
- Has undiagnosed abnormal uterine bleeding. Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Candiolo, TO, Italy
- Pozuelo de Alarcón, Madrid, Spain
- Barcelona, Spain
- Madrid, Spain
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Candiolo, TO, Italy; Pozuelo de Alarcón, Madrid, Spain; Barcelona, Spain; Madrid, Spain. 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.