A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies

Study Identifier:
CDAK539A12102
CT.gov Identifier:
NCT07340190
EudraCT Identifier:
202552100022
EU Trial (CTIS) Number:
2025-521000-22-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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.

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.
Unspecified Cancer
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.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Arm A
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Drug: Part 1 (PK profiles of victim drugs):
Drug: • Arm A: repaglinide + midazolam + pelabresib
Drug: Part 2 (Continued treatment):
Drug: After completing Part 1, in case of clinical benefit, participants can continue with pelabresib treatment in Part 2 until the end of study (EOS) is reached or until the participant meets discontinuation criteria, or until they receive pelabresib treatment via alternative means of access, whichever occurs first.
Drug: Drug: midazolam
Drug: 2 mg/mL midazolam oral solution administered orally on Pre-Cycle Day 1 and Cycle 1 Day 14
Drug: Drug: pelabresib
Drug: pelabresib 225 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break
Drug: Other Names: DAK539 (formerly CPI-0610)
Drug: Drug: repaglinide
Drug: 0.5 mg repaglinide tablet administered orally on Pre-Cycle Day 1 and Cycle 1 Day 14
Drug: EXPERIMENTAL: Arm B
Drug: • Arm B: drospirenone + ethinyl estradiol + pelabresib
Drug: Drug: drospirenone
Drug: 3 mg drospirenone tablet administered orally on Pre-Cycle Day 1 and Cycle 1 Day 10
Drug: Drug: ethinyl estradiol
Drug: 0.03 mg ethinyl estradiol tablet administered orally on Pre-Cycle Day 1 and Cycle 1 Day 10
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Key inclusion criteria 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:
  • 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. 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.
  • 4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤5 × ULN if the elevation can be ascribed to liver involvement)
  • 6. 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 for Arm B
  • • Is a female participant.
  • Key
Exclusion criteria
  • 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 repaglinide, including any unresolved nausea, vomiting, or diarrhea.
  • Key exclusion criteria for Arm B
  • * 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 estradiol, including any unresolved nausea, vomiting, or diarrhea.
  • * Has breast cancer or other estrogen- or progestin-sensitive cancer.
  • * Has undiagnosed abnormal uterine bleeding.
  • 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 Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Manuel Pedregal Trujillo
Status
Recruiting
Condition(s) Treated at Site
Unspecified Cancer