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Kinase Inhibitor

Vimseltinib for Tenosynovial Giant Cell Tumor (MOTION Trial)

Phase 3
Waitlist Available
Research Sponsored by Deciphera Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic disease as defined as at least moderate pain or at least moderate stiffness within the screening period and documented in the medical record
TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 25 (cycle 7, day 1)
Awards & highlights

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.

Who is the study for?
Adults with tenosynovial giant cell tumor (TGCT) that can't be surgically removed. They must have a confirmed diagnosis, measurable disease, stable pain management, and no allergies to the study drug. Women of childbearing age need a negative pregnancy test and must follow contraception guidelines.Check my eligibility
What is being tested?
The trial is testing vimseltinib against a placebo for TGCT treatment over 24 weeks. Participants will undergo physical exams, blood tests, imaging studies including MRI scans to monitor tumor response. Afterward, all participants can receive vimseltinib in an open-label extension phase.See study design
What are the potential side effects?
Specific side effects are not listed here but may include typical reactions related to oral medications such as digestive issues or allergic reactions; plus any potential unique effects of vimseltinib which would be monitored through assessments during the trial.

MOTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate pain or stiffness noted in my medical records.
Select...
My TGCT cannot be removed surgically, and I may need a biopsy to confirm this if no previous tests are available.
Select...
I am 18 years old or older.
Select...
My pain medication has not changed in the last 2 weeks.
Select...
I have a tumor that can be measured and is at least 2cm big.

MOTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 25 (cycle 7, day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 25 (cycle 7, day 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR= complete response [CR]+partial response [PR]) per RECIST Version 1,1
Secondary outcome measures
ORR per Tumor Volume Score (TVS)
Physical function
Quality of life (QoL)
+3 more

MOTION Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 1/Part 2 - vimseltinib/vimseltinibExperimental Treatment1 Intervention
Participants receive blinded treatment of 30 mg twice a week (biw) vimseltinib for 24 weeks in Part 1 and continue on 30 mg biw vimseltinib in Part 2
Group II: Part 1/Part 2 - placebo/vimseltinibPlacebo Group2 Interventions
Participants receive blinded treatment of 30 mg twice a week (biw) matching placebo for 24 weeks in Part 1 and have option to receive 30 mg biw vimseltinib in Part 2

Find a Location

Who is running the clinical trial?

Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
2,107 Total Patients Enrolled

Media Library

Vimseltinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05059262 — Phase 3
Giant Cell Tumor Research Study Groups: Part 1/Part 2 - placebo/vimseltinib, Part 1/Part 2 - vimseltinib/vimseltinib
Giant Cell Tumor Clinical Trial 2023: Vimseltinib Highlights & Side Effects. Trial Name: NCT05059262 — Phase 3
Vimseltinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059262 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Manitoba
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Good day this is Mr Badalov Eduard , residing in Winnipeg Manitoba Canada , born in Soviet Union in Jewish tradition Russian speaking family in Uzbekistan which is now a Muslim country , grew up in Israel as a student & immigrated to Canada in 2008 .
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
2021. "Study of Vimseltinib for Tenosynovial Giant Cell Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05059262.
~33 spots leftby May 2025
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