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Phase 2, Single-arm Study to Investigate the Tolerability, Pharmacokinetics, Efficacy, and Safety of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is \[i.e.\] it is located in a complex anatomical site, extensively invasive, and cannot be completely resected; or a surgical operation may cause dysfunction or serious complications). Symptomatic disease because of active TGCT, defined as a worst pain of greater than or equal to \[\>=\] 4 within 2 weeks prior to enrollment (based on scale of 0 to 10, with 10 representing pain as bad as you can imagine), and/or a worst stiffness of \>= 4 within 2 weeks prior to first dose of pimicotinib (based on a scale of 0 to 10, with 10 representing stiffness as bad as you can imagine)

• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to \[\<=\] 1

• Participants with adequate hepatic, renal hematologic functions

• Other protocol defined inclusion criteria may apply

Locations
Other Locations
Japan
Kyushu University Hospital - 300173484
RECRUITING
Fukuoka
Contact Information
Primary
Communication Center
service@emdgroup.com
+49 6151 72 5200
Time Frame
Start Date: 2026-03-26
Estimated Completion Date: 2029-11-22
Participants
Target number of participants: 20
Treatments
Experimental: Safety Run-In followed by Expansion Cohort: Pimicotinib
Related Therapeutic Areas
Sponsors
Leads: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborators: Merck KGaA, Darmstadt, Germany

This content was sourced from clinicaltrials.gov