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Vimseltinib for Tenosynovial Giant Cell Tumor (MOTION Trial)
MOTION Trial Summary
This trial is testing if the drug vimseltinib can help people with a certain kind of tumor who can't have surgery. There are two parts to the study. In the first part, people will either get the drug or a fake (placebo) version for 24 weeks. There are a lot of different tests that will be done during the study to see how people are doing. If people do well on the fake drug in the first part, they can take the real drug in the second part.
MOTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMOTION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MOTION Trial Design
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Who is running the clinical trial?
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- I am currently pregnant or breastfeeding.I have a liver condition like NASH or cirrhosis.I experience moderate to severe pain or stiffness.I have been treated for TGCT and was in a drug study not related to TGCT within the last 30 days.I have moderate pain or stiffness noted in my medical records.I do not have conditions that affect how my body absorbs medication.My TGCT cannot be removed surgically, and I may need a biopsy to confirm this if no previous tests are available.I have not used treatments targeting CSF1 or CSFR1, except imatinib or nilotinib.I have not had major surgery within the last 2 weeks.I do not have active HIV, hepatitis B, hepatitis C, or tuberculosis.My organs and bone marrow are working well.I am 18 years old or older.I have another cancer that needs treatment besides TGCT.My pain medication has not changed in the last 2 weeks.I have a tumor that can be measured and is at least 2cm big.
- Group 1: Part 1/Part 2 - placebo/vimseltinib
- Group 2: Part 1/Part 2 - vimseltinib/vimseltinib
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the FDA sanction vimseltinib for public use?
"Vimseltinib's safety is estimated to be a 3. This determination comes from the fact that vimseltinib is in Phase 3 clinical trials, which suggests that there is both efficacy and safety data supporting its use."
Are there any current openings for participants in this research trial?
"That is correct. If you consult clinicaltrials.gov, you will see that this trial was last updated on October 18th, 2022 and is currently looking for 120 people to fill the 15 available spots."
Is this clinical trial available in many different locations throughout the United States?
"Patients are being enrolled for this clinical trial at McGill University in Toronto, Minnesota, University of Kansas in Kansas City, Ohio, and Mayo Clinic Rochester in Rochester, North carolina as well as other sites."
How many people are being signed up for this trial?
"120 eligible patients are required for the study to have enough statistical power. The sponsor, Deciphera Pharmaceuticals LLC, will be enrolling patients from different locations such as McGill University in Toronto, Minnesota and University of Kansas in Kansas City, Ohio."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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