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Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

NCT03069469•Deciphera Pharmaceuticals, LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

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.
+21 more criteria

Locations (24)

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

Key Dates

Start Date

February 16, 2017

Primary Completion Date

July 1, 2026

Completion Date

August 1, 2028

Last Updated

December 18, 2025

Enrollment

120

ESTIMATED participants

Conditions

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

Interventions

Vimseltinib

DRUG

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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RECRUITINGPHASE1/PHASE2

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Advanced Malignant NeoplasmAdvanced or Metastatic Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

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