Centre Leon Berard
Verified
Lyon, France
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a medication called vimseltinib, also known by its code name DCC-3014. The study is designed to assess the safety and effectiveness of this medication in patients with advanced tumors and a specific type of tumor called tenosynovial giant cell tumor (TGCT). TGCT is a condition that affects the joints and can cause pain and stiffness. The purpose of the study is to understand how well vimseltinib works in treating these conditions and to determine the best dose for future use.
Participants in the study will take vimseltinib in the form of a hard capsule, which is taken orally. The study will monitor the participants over a period of time to observe any side effects and to measure how the medication is processed in the body. This includes looking at how long it takes for the medication to reach its highest level in the blood and how long it stays in the system. The study will also evaluate the medication's ability to reduce the size of the tumors using specific criteria for measuring tumor response.
The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study will continue until the researchers gather enough information to determine the safety and effectiveness of vimseltinib for treating advanced tumors and TGCT. The findings from this study will help guide future research and treatment options for these conditions.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
13 criteria
12 criteria
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Lyon, France
Milan, Italy
Leiden, The Netherlands
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Advanced tumors refer to cancerous growths that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These tumors can affect various organs and tissues, leading to a range of symptoms depending on their location and size. As they grow, they may invade nearby structures and disrupt normal bodily functions. The progression of advanced tumors can vary widely, with some growing slowly over time, while others may spread rapidly. The impact on the body can be significant, often causing pain, fatigue, and other systemic effects.
Tenosynovial giant cell tumor is a rare, typically benign tumor that arises in the synovial lining of joints, tendons, or bursae. It is characterized by the proliferation of synovial-like cells, leading to swelling and pain in the affected area. The tumor can be localized or diffuse, with the localized form often presenting as a single mass, while the diffuse form can involve larger areas. Over time, the tumor may cause joint stiffness and reduced mobility due to its growth and pressure on surrounding tissues. Although it is generally non-cancerous, it can cause significant discomfort and functional impairment.
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