Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

Keywords

Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath Tenosynovial Giant Cell Tumor, Diffuse Tenosynovial Giant Cell Tumor, Localized TGCT PVNS Neoplasms Giant Cell Tumors Synovitis, Pigmented Villonodular Synovitis vimseltinib

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients ≥18 years of age
  2. TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
  3. 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
  4. Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol
  5. Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug
  6. Must have measurable disease, as per RECIST Version 1.1, with at least one lesion having a minimum size of 2cm
  7. Adequate organ and bone marrow function
  8. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
  9. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures
  10. . Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device

You CAN'T join if...

  1. Previous use of systemic therapy (investigational or approved) targeting colony stimulating factor 1 (CSF1) or CSFR1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed
  2. Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening.
  3. Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis)
  4. QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome
  5. Concurrent treatment with any study-prohibited medications
  6. Major surgery within 14 days of the first dose of study drug
  7. Any clinically significant comorbidities
  8. Active liver or biliary disease including nonalcoholic steatohepatitis (NASH) or cirrhosis
  9. Malabsorption syndrome or other illness that could affect oral absorption
  10. . Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection
  11. . If female, the participant is pregnant or breastfeeding
  12. . Known allergy or hypersensitivity to any component of the study drug
  13. . Contraindication to MRI

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Deciphera Pharmaceuticals LLC
ID
NCT05059262
Phase
Phase 3 research study
Study Type
Interventional
Last Updated