Phase
Condition
Neoplasms
Soft Tissue Infections
Arthritis And Arthritic Pain
Treatment
Vimseltinib
Placebo
vimseltinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients ≥18 years of age
TGCT for which surgical resection is not an option (tumor biopsy to confirmdiagnosis required if no histology/pathology available at screening)
Symptomatic disease as defined as at least moderate pain or at least moderatestiffness (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 thescreening period and must meet minimum requirements as outlined in study protocol
Must have stable analgesic regimen, as judged by the investigator, for at least 2weeks prior to first dose of study drug
Must have measurable disease, as per RECIST Version 1.1, with at least one lesionhaving a minimum size of 2cm
Adequate organ and bone marrow function
If a female of childbearing potential, must have a negative pregnancy test prior toenrollment and agree to follow the contraception requirements
Must provide signed consent to participate in the study and is willing to complywith study-specific procedures
Willing and able to complete the patient-reported outcome (PRO) assessments on anelectronic device
Exclusion
Exclusion Criteria:
Previous use of systemic therapy (investigational or approved) targetingcolony-stimulating factor 1 (CSF1) or colony-stimulating factor 1 receptor (CSF1R);previous therapy with imatinib and nilotinib is allowed
Received therapy for TGCT, including investigational therapy during the screeningperiod. Participated in a non-TGCT investigational drug study within 30 days ofscreening.
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 infemales 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) orcirrhosis
Malabsorption syndrome or other illness that could affect oral absorption
Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acuteor 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
Study Design
Connect with a study center
Chris O'Brien Lifehouse
Camperdown,
AustraliaSite Not Available
Princess Margaret Hospital
Montreal,
CanadaSite Not Available
McGill University
Montréal,
CanadaSite Not Available
Princess Margaret Hospital
Toronto,
CanadaSite Not Available
Institut Bergonié
Bordeaux,
FranceSite Not Available
Centre Léon Bérard
Lyon,
FranceSite Not Available
Institut Gustave Roussy
Villejuif,
FranceSite Not Available
Helios Klinikum Berlin-Buch
Berlin,
GermanySite Not Available
University Hospital Essen (Universitätsklinikum Essen)
Essen,
GermanySite Not Available
Prince of Wales Hospital
Hong Kong,
Hong KongSite Not Available
Istituto Ortopedico Rizzoli
Bologna,
ItalySite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan,
ItalySite Not Available
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples,
ItalySite Not Available
Istituto Oncologico Veneto
Padua,
ItalySite Not Available
Istituto Nazionale Tumori Regina Elena
Rome,
ItalySite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
Leiden University Medical Center
Leiden,
NetherlandsSite Not Available
Oslo University Hospital
Oslo,
NorwaySite Not Available
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw,
PolandSite Not Available
Hospital Universitario Vall d'Hebron
Barcelona,
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona,
SpainSite Not Available
Fundacion Jimenez Diaz
Madrid,
SpainSite Not Available
Hospital Clinico San Carlos
Madrid,
SpainSite Not Available
Universitäts-Kinderspital beider Basel (UKBB)
Basel,
SwitzerlandSite Not Available
Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
London,
United KingdomSite Not Available
University College London Hospitals
London,
United KingdomSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United StatesSite Not Available
University of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
University of Kansas
Kansas City, Kansas 66160
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55902
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10016
United StatesSite Not Available
Duke Sarcoma Research
Durham, North Carolina 27710
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesSite Not Available
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