Phase 1b Study to Assess How Pelabresib Affects the Bodys Processing of Repaglinide, Midazolam, and Combined Oral Contraceptives in Adults With Advanced Cancer

What this Trial Is About

Researchers are evaluating the impact of pelabresib on the pharmacokinetics of repaglinide, midazolam, and combined oral contraceptives containing drospirenone and ethinyl estradiol in adults with advanced malignancies who have no standard or curative treatment options. This Phase 1b study is designed to understand drug-drug interactions and assess continued treatment benefits in participants with these conditions. The study has two parts In Part 1, participants receive pelabresib 225 mg orally once daily for 14 days followed by a 7-day break. Arm A assesses interactions with single doses of repaglinide and midazolam, involving two hospital stays Arm B evaluates interactions with combined drospirenone and ethinyl estradiol, with hospital stays lasting from 2 to 10 nights. Part 2 allows participants who show clinical benefit to continue pelabresib treatment in additional cycles until study end or discontinuation criteria are met. Participants undergo screening before enrollment and receive assigned doses through an interactive response system. Assessments include plasma concentration measurements and pharmacokinetic profiles of the drugs at specific time points during 21-day cycles. Safety monitoring includes adverse event tracking up to 30 days after treatment ends, and participants with hematological malignancies have follow-up every 3 months for leukemic transformation until study completion or other defined endpoints. Total participation includes screening, treatment, follow-up, and monitoring phases.

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