Full Title
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION) (WIRB)Purpose
The purpose of this study is to compare the safety and effectiveness of the investigational drug vimseltinib with a placebo (inactive drug) in people with inoperable tenosynovial giant cell tumor, a type of cancer that develops in a joint. Vimseltinib blocks the activity of changes in the CSF1R genes, which can lead to tumor overgrowth in the joint. Blocking these genes may stop or slow tumor growth.
Patients in this study will be randomly assigned to receive vimseltinib or a placebo. Those in the placebo group will be able to receive vimseltinib after 24 weeks. Vimseltinib is taken orally (by mouth).
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have tenosynovial giant cell tumor that cannot be surgically removed and is causing moderate to severe pain or joint stiffness.
- At least 2 weeks must pass since the completion of prior therapies and receipt of the study treatment.
- This study is for people age 18 and older.
For more information and to ask about eligibility for this study, please contact Dr. William Tap at 646-888-4163.