Pimicotinib for Japanese people with tenosynovial giant cell tumor (J-MANEUVER)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives oral pimicotinib, a CSF-1R inhibitor, to Japanese adults with histologically confirmed, unresectable tenosynovial giant cell tumor. The study includes a safety run-in cohort followed by an expansion cohort to characterize tolerability, pharmacokinetics, efficacy, and overall safety. Eligible participants are symptomatic (worst pain or stiffness ≥4), have ECOG performance status 0–1, and adequate organ function, and they attend regular clinic visits for imaging, labs, and symptom assessments. Primary outcomes focus on tolerability and PK, with secondary outcomes measuring tumor response and changes in symptoms and function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Known additional malignancy that required active treatment and may affect the participant's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ
* Serious gastrointestinal bleeding within 3 months of first dose of pimicotinib or factors that significantly affected the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small-bowel resection, etc.
* Impaired cardiac function or clinically significant cardiac disease, including any one of the following: New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure; prolongation of the rate corrected QT interval based on repeated demonstration of QT interval corrected using Fridericia's formula (QTcF) greater than (\>) 480 milliseconds (ms), or history of long QT interval corrected (QTc) syndrome; Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) or below the lower limit of normal, whichever is higher
* Cerebrovascular accident/stroke (within 6 months of first dose of pimicotinib)
* Other protocol defined exclusion criteria may apply

Where it's running

• National Cancer Center Hospital
  Chūōku, Japan Recruiting
• Kyushu University Hospital - 300173484
  Fukuoka, Japan Recruiting
• Kanazawa University Hospital
  Kanazawa, Japan Recruiting
• Nagoya University Hospital - 300176284
  Nagoya, Japan Recruiting

Study contacts

• Study coordinator: Communication Center
• Email: service@emdgroup.com
• Phone: +49 6151 72 5200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Indocyanine green fluorescence to find leftover giant cell tumor tissue during surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.