Active — Not RecruitingPhase 3

Study of Vimseltinib for Tenosynovial Giant Cell Tumor

United States123 participantsStarted 2021-10-14

Plain-language summary

This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients ≥18 years of age
✓. TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
✓. Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record
✓. Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol
✓. Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug
✓. Must have measurable disease, as per RECIST Version 1.1, with at least one lesion having a minimum size of 2cm
✓. Adequate organ and bone marrow function
✓. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements

Exclusion criteria

What they're measuring

Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

Timeframe: Baseline to Week 25 (Cycle 7, Day 1)

Trial details

NCT IDNCT05059262

SponsorDeciphera Pharmaceuticals, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-10

Results submitted2025-01-13

View on ClinicalTrials.gov More Tenosynovial Giant Cell Tumor trials