MANEUVER: A Phase III study of pimicotinib to assess efficacy and safety in tenosynovial giant cell tumor patients.
Xiaohui NiuVinod RaviBoyao ShanQiuxiang GuoHaosong ShiQingping ZouAndré B P van KuilenburgPublished in: Future oncology (London, England) (2024)
Tenosynovial giant cell tumor (TGCT) is a rare, locally invasive soft tissue tumor arising from the synovium of joints, bursa and tendon sheaths and is associated with the overexpression of the colony-stimulating factor 1 (CSF-1) gene. Pimicotinib is an orally available, highly selective and potent small molecule CSF-1 receptor (CSF-1R) inhibitor with robust efficacy and safety profile in patients with TGCT and is under development in multiple diseases. In an open-label Phase I study in patients with TGCT not amenable to surgery, pimicotinib showed superior efficacy and safety. In this article, we elucidate the rationale and study design of the multi-region Phase III MANEUVER trial (NCT05804045), which is designed to assess the efficacy and safety of pimicotinib in patients with TGCT not amenable to surgical resection in Asia, North America and Europe.
Keyphrases
- giant cell
- phase iii
- clinical trial
- open label
- small molecule
- phase ii
- double blind
- end stage renal disease
- placebo controlled
- soft tissue
- ejection fraction
- newly diagnosed
- chronic kidney disease
- cell proliferation
- randomized controlled trial
- minimally invasive
- prognostic factors
- coronary artery bypass
- cerebrospinal fluid
- dna methylation
- copy number
- peritoneal dialysis
- anti inflammatory
- genome wide analysis