Actively Recruiting
Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)
Led by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT
CONDITIONS
Official Title
Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Japanese participants diagnosed with Tenosynovial Giant Cell Tumor (TGCT) confirmed by local laboratory and deemed unresectable
- Symptomatic disease with worst pain or stiffness of 4 or higher within 2 weeks before enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate liver, kidney, and blood function
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Presence of another active cancer requiring treatment, except for certain cured skin cancers and carcinoma in situ
- Serious gastrointestinal bleeding within 3 months before starting pimicotinib or conditions affecting oral drug absorption
- Significant heart problems including severe heart disease, uncontrolled cardiac conditions, or prolonged QT interval
- Stroke or cerebrovascular accident within 6 months before starting pimicotinib
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kyushu University Hospital - 300173484
Fukuoka, Japan
Actively Recruiting
Research Team
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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