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Clinical Trials in the USA / NCT03069469
Active, not recruiting Phase 1/2

Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

NCT03069469 · tracked via the Priya Life Science USA tracker
Sponsor
Deciphera Pharmaceuticals, LLC
Phase
Phase 1/2
Started
2017-02-16
Last updated
2026-06-25

Condition(s) studied

Advanced Malignant NeoplasmPigmented Villonodular SynovitisGiant Cell Tumor of Tendon SheathTenosynovial Giant Cell TumorTenosynovial Giant Cell Tumor, Diffuse

Investigational drug(s) / intervention(s)

Vimseltinib

Vimseltinib: Colony-stimulating factor 1 receptor (CSF1R) inhibitor

Study summary

This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria Dose Escalation Phase: 1. Patients ≥18 years of age 2. Patients must have: 1. advanced malignant solid tumors; or 2. symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening) 3. Malignant solid tumor patients only: Able to provide a tumor tissue sample 4. Must have 1 measurable lesion according to RECIST Version 1.1 5. Malignant solid tumor patients only: Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Adequate organ and bone marrow function 7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements. 8. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures. Expansion Phase (Cohorts A and B) 1. Patients ≥18 years of age 2. Patients must have symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening) a) Expansion Cohort B: patients must have prior systemic treatment with anti-CSF1 or anti-CSF1R therapy, with the exception of imatinib or nilotinib 3. Adequate organ and bone marrow function 4. Must have at least 1 measurable lesion according to RECIST Version 1.1 5. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements. 6. Must provide signed consent to participate in the study and is willing to comply with study-specific procedures. Exclusion Criteria Dose Escalation Phase: 1. Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug. 2. Unresolved toxicity (Grade \>1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia. 3. Known active central nervous system (CNS) metastases. 4. History or presence of clinically relevant cardiovascular abnormalities. 5. Systemic arterial or venous thrombotic or embolic events. 6. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome. 7. Left ventricular ejection fraction (LVEF) \<50%. 8. Concurrent treatment with proton-pump inhibitor(s). 9. Major surgery within 2 weeks of the first dose of study drug. 10. Malabsorption syndrome or other illness that could affect oral absorption. 11. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection. 12. If female, the patient is pregnant or lactating. 13. Known allergy or hypersensitivity to any component of the study drug. 14. Any other clinically significant comorbidities. Expansion Phase (Cohorts A and B) 1. Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed. 2. Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury. 3. Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug. 4. Known metastatic TGCT or other active cancer that requires concurrent treatment. 5. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome. 6. Left ventricular ejection fraction (LVEF) \<55%. 7. Concurrent treatment with proton-pump inhibitor(s). 8. Major surgery within 2 weeks of the first dose of study drug. 9. Any clinically significant comorbidities 10. Malabsorption syndrome or other illness that could affect oral absorption. 11. Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection. 12. If female, the patient is pregnant or lactating. 13. Known allergy or hypersensitivity to any component of the study drug. 14. Contraindication for MRI 15. Active liver or biliary disease, including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Stanford Cancer Institute Palo Alto California
University of Colorado - Denver Denver Colorado
Mayo Clinic Jacksonville Florida
University of Miami Miami Florida
Dana Farber Boston Massachusetts
MSKCC New York New York
OHSU Portland Oregon
Oregon Health & Science University Portland Oregon
Sarah Cannon Research Institute Nashville Tennessee
Peter MacCallum Cancer Centre Melbourne Australia
McGill University Health Centre Montreal Quebec
Princess Margaret Cancer Center Toronto Canada
Centre Leon Berard Lyon France
Gustave Roussy Cancer Campus Grand Paris Paris France
IRCCS Istituto Ortopedico Rizzoli Bologna Italy
Fondazione IRCCS Istituto Nazionale Dei Tumori Milan Italy
Istituto Nazionale dei Tumori Milan Italy
Regina Elena National Cancer Institute Rome Italy
Leiden University Medical Center Leiden Netherlands
M. Sklodowska-Curie Memorial Cancer Center Warsaw Poland
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Clinico San Carlos Madrid Spain
Hospital Universitario Virgen del Rocío, Sevilla Seville Spain
University College Hospital London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03069469 on ClinicalTrials.gov ↗ ← All trials in the USA