Trial record 1 of 1 for:
NCT05059262
Study of Vimseltinib for Tenosynovial Giant Cell Tumor (MOTION)
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| ClinicalTrials.gov Identifier: NCT05059262 |
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Recruitment Status :
Active, not recruiting
First Posted : September 28, 2021
Last Update Posted : March 16, 2023
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Sponsor:
Deciphera Pharmaceuticals LLC
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
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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 |
| 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 |
|---|---|
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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
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Drug: vimseltinib
CSF1R inhibitor
Other Name: DCC-3014 |
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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
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Drug: vimseltinib
CSF1R inhibitor
Other Name: DCC-3014 Drug: Placebo Placebo |
Primary Outcome Measures :
- 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 :
- 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.
- 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
- 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
- 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
- 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
- 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:
- 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
- Must provide signed consent to participate in the study and is willing to comply with study-specific procedures
- Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device
Exclusion Criteria:
- 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
- Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening.
- Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis)
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome
- Concurrent treatment with any study-prohibited medications
- Major surgery within 14 days of the first dose of study drug
- Any clinically significant comorbidities
- Active liver or biliary disease including nonalcoholic steatohepatitis (NASH) or cirrhosis
- Malabsorption syndrome or other illness that could affect oral absorption
- Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection
- If female, the participant is pregnant or breastfeeding
- Known allergy or hypersensitivity to any component of the study drug
- 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
Locations
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Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
| 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: | March 16, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Deciphera Pharmaceuticals LLC:
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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 |