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Study of Vimseltinib for Tenosynovial Giant Cell Tumor (MOTION)

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ClinicalTrials.gov Identifier: NCT05059262
Recruitment Status : Recruiting
First Posted : September 28, 2021
Last Update Posted : October 19, 2022
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Brief 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.


Condition or disease Intervention/treatment Phase
Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath Tenosynovial Giant Cell Tumor, Diffuse Tenosynovial Giant Cell Tumor, Localized Drug: vimseltinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 14, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1/Part 2 - vimseltinib/vimseltinib
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
Drug: vimseltinib
CSF1R inhibitor
Other Name: DCC-3014

Placebo Comparator: Part 1/Part 2 - placebo/vimseltinib
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
Drug: vimseltinib
CSF1R inhibitor
Other Name: DCC-3014

Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Objective Response Rate (ORR= complete response [CR]+partial response [PR]) per RECIST Version 1,1 [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Assessed by central read using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1


Secondary Outcome Measures :
  1. ORR per Tumor Volume Score (TVS) [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Assessed by central read using Tumor Volume Score (TVS). TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.

  2. Range of motion (ROM) [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Mean change from baseline in active ROM of the affected joint, relative to a reference standard at Week 25

  3. Physical function [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Mean change from baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) physical function score at Week 25

  4. Worst stiffness [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score at Week 25

  5. Quality of life (QoL) [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Mean change from baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25

  6. Worst pain [ Time Frame: Baseline to Week 25 (Cycle 7, Day 1) ]
    Proportion of responders, with a response defined as at least a 30% improvement in the mean Brief Pain Inventory (BPI) Worst Pain NRS score without a 30% or greater increase in narcotic analgesic use at Week 25



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059262


Contacts
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Contact: Clinical Team 785-830-2100 clinicaltrials@deciphera.com

Locations
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Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT05059262    
Other Study ID Numbers: DCC-3014-03-001
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deciphera Pharmaceuticals LLC:
TGCT
PVNS
Additional relevant MeSH terms:
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Neoplasms
Giant Cell Tumors
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Synovitis
Joint Diseases
Musculoskeletal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Tendinopathy
Muscular Diseases