Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
NCT ID: NCT03069469
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2017-02-16
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Experimental Treatment
Dose Escalation Phase: Increasing doses of vimseltinib beginning at 10 milligram (mg) once daily (QD) for 28 day cycles until disease progression or unacceptable toxicity.
Expansion Phase: Dosing of different patient cohorts at the dose level determined from the Dose Escalation Phase of the study.
Vimseltinib
Colony-stimulating factor 1 receptor (CSF1R) inhibitor
Interventions
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Vimseltinib
Colony-stimulating factor 1 receptor (CSF1R) inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Deciphera Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Maitreyi Sharma, MD
Role: STUDY_DIRECTOR
Deciphera Pharmaceuticals, LLC
Locations
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Stanford Cancer Institute
Palo Alto, California, United States
University of Colorado - Denver
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Dana Farber
Boston, Massachusetts, United States
MSKCC
New York, New York, United States
OHSU
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Peter MacCallum Cancer Centre
Melbourne, , Australia
McGill University Health Centre
Montreal, Quebec, Canada
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
Countries
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Other Identifiers
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DCC-3014-01-001
Identifier Type: -
Identifier Source: org_study_id
2024-514933-39-00
Identifier Type: CTIS
Identifier Source: secondary_id