Phase 2 Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) Assessing Tolerability, Pharmacokinetics, Efficacy, and Safety

What this Trial Is About

Researchers are evaluating the tolerability, pharmacokinetics, efficacy, and safety of pimicotinib in Japanese participants diagnosed with Tenosynovial Giant Cell Tumor (TGCT), a condition confirmed by local laboratory testing and characterized by tumors that cannot be surgically removed or where surgery may cause serious complications. This phase 2 study includes two groups: a Safety Run-in cohort and an Expansion cohort. The study is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, and aims to understand how pimicotinib behaves in the body and its effects on this tumor type. Participants in the Safety Run-in cohort receive 50 milligrams of pimicotinib orally once daily in 28-day cycles, continuing until disease progression, death, or other reasons for stopping. Following safety assessment by a monitoring committee, participants in the Expansion cohort will also receive 50 mg pimicotinib daily under the same conditions. The study measures drug concentration in the blood and monitors dose-limiting toxicities during the initial 28 days of treatment. During the study, participants will undergo regular assessments including scans evaluated by an independent review committee to track tumor response according to standardized criteria over approximately two years. Other evaluations include pain and stiffness ratings, physical function questionnaires, and quality of life scales at baseline and week 25. Safety is monitored through adverse event reporting throughout the study period, and pharmacokinetic data are collected at specific times during the first treatment cycle to understand how the drug is processed in the body.

Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)