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New treatment option for Tenosynovial Giant Cell Tumor
Official title Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)
ClinicalTrials.gov ID: NCT07499362
What this study is testing
What is Pimicotinib?
Pimicotinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tenosynovial giant cell tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is [i.e.] it...
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to [\<=] 1
- Participants with adequate hepatic, renal hematologic functions
- Other protocol defined may apply
You likely can't join if
- Known additional malignancy that required active treatment and may affect the participant's participation in the study or affect the outcome of the...
- Serious gastrointestinal bleeding within 3 months of first dose of pimicotinib or factors that significantly affected the absorption of oral drug...
- Impaired cardiac function or clinically significant cardiac disease, including any one of the following: New York Heart Association (NYHA) class III...
- Cerebrovascular accident/stroke (within 6 months of first dose of pimicotinib)
- Other protocol defined exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Chūōku, Japan
- Fukuoka, Japan
- Nagoya, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chūōku, Japan; Fukuoka, Japan; Nagoya, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.