| Titre |
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor |
| Protocole ID |
DCC-3014-03-001 (MOTION) |
| ClinicalTrials.gov ID |
NCT05059262 |
| Type(s) de cancer |
Sarcome |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Vimseltinib |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Thierry Alcindor
|
| Coordonnateur(trice) |
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- 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 per BPI Worst Pain or at least moderate stiffness per Worst Stiffness NRS item (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period, prior to the first dose, 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 at least 1 measurable lesion according to RECIST Version 1.1, with a minimum tumor 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
|
| Critètes d'exclusion |
- Previous use of systemic therapy 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 within 14 days prior to the administration of study drug or within 28 days for therapies with a half-life longer than 3 days or an unknown half-life prior to the administration of study drug
- 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 evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis
- Malabsorption syndrome or other illness that could affect oral absorption
- Known active human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or known active mycobacterium tuberculosis infection
- If female, the participant is pregnant or lactating
- Known allergy or hypersensitivity to any component of the study drug
- Contraindication to MRI
|
Groupe d'étude en oncologie du Québec