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

Inclusion Criteria12

• 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 for Arm B
• Is a female participant.