Vimseltinib for Tenosynovial Giant Cell Tumor
(MOTION Trial)

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Deciphera Pharmaceuticals, LLC

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medicine called vimseltinib for patients with a type of tumor called TGCT who can't have surgery. The medicine aims to block proteins that help the tumor grow, potentially shrinking it or stopping its growth. Vimseltinib has shown promising results in early studies for TGCT.

Eligibility Criteria

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.

Inclusion Criteria

Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol

I have moderate pain or stiffness noted in my medical records.

My TGCT cannot be removed surgically, and I may need a biopsy to confirm this if no previous tests are available.

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Exclusion Criteria

Concurrent treatment with any study-prohibited medications

Known allergy or hypersensitivity to any component of the study drug

I am currently pregnant or breastfeeding.

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Treatment Details

Interventions

Placebo (Other)
Vimseltinib (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 1/Part 2 - Vimseltinib/VimseltinibExperimental Treatment1 Intervention

Participants received blinded treatment of 30 mg twice a week (BIW) vimseltinib for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2.

Group II: Part 1/Part 2: Placebo/VimseltinibPlacebo Group2 Interventions

Participants received blinded treatment of BIW matching placebo for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2.