Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
- Conditions
- Giant Cell Tumor of Tendon SheathTenosynovial Giant Cell Tumor, DiffuseAdvanced Malignant NeoplasmTenosynovial Giant Cell TumorPigmented Villonodular Synovitis
- Interventions
- Registration Number
- NCT03069469
- Lead Sponsor
- Deciphera Pharmaceuticals, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental Treatment Vimseltinib 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.
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) Day 1 - Day 28 of Cycle 1 for each dose level tested Determine the maximum tolerated dose.
Number of Patients with Dose-Limiting Toxicities (DLTs) Day 1- Day 28 of Cycle 1 for each dose level tested Identify the number of patients with DLTs for each dose level tested.
Area under the concentration-time curve (AUC) of Vimseltinib Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose) Measure the AUC of vimseltinib.
Time to maximum observed concentration of Vimseltinib Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose) Measure the time to maximum plasma concentration of vimseltinib in patients.
Trough observed concentration of Vimseltinib Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose) Measure the observed trough concentration of vimseltinib in patients.
Maximum observed concentration of Vimseltinib Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose) Measure the maximum observed concentration of vimseltinib in patients.
Objective response rate (ORR= complete response [CR]+partial response [PR]) (Expansion Phase only) At Week 25 (Cycle 7, Day 1) Assessed by central read using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Duration of response rate (DOR) (Expansion Phase only) Date from PR or CR to disease progression or death (Estimated up to 24 months) Measure time from partial response (PR) or complete response (CR) to disease progression or death.
Half life of Vimseltinib Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 (pre-dose and at multiple time points (up to 8 hours) post-dose) Measure half life of vimseltinib in patients.
- Secondary Outcome Measures
Name Time Method Worst Stiffness Numeric Rating Scale (NRS) Score (Expansion Phase only) Baseline to Week 25 (Cycle 7, Day 1) Analysis of patient reported outcomes based upon the Worst Stiffness Numeric Rating Scale (NRS)
Range of Motion (ROM) (Expansion Phase only) Baseline to Week 25 (Cycle 7, Day 1) Measure mean change from baseline in relative ROM
Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only) Baseline to Week 25 (Cycle 7, Day 1) Analysis of patient reported outcomes based upon the patient-reported outcomes measurement information system (PROMIS) physical function questionnaire
Response rate (Expansion Phase only) At Week 25 (Cycle 7, Day 1) Assessed by central read using tumor volume score and modified RECIST (mRECIST) Version 1.1
Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) Score (Expansion Phase only) Baseline to Week 25 (Cycle 7, Day 1) Proportion of responders based on Brief Pain Inventory (BPI) worst pain numeric rating scale (NRS) and narcotic analgesic use by Brief Pain Inventory-30 (BPI-30)
Trial Locations
- Locations (24)
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
MSKCC
🇺🇸New York, New York, United States
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Australia
Princess Margaret Cancer Center
🇨🇦Toronto, Canada
Gustave Roussy Cancer Campus Grand Paris
🇫🇷Paris, France
Centre Leon Berard
🇫🇷Lyon, France
IRCCS Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Leiden University Medical Center
🇳🇱Leiden, Netherlands
M. Sklodowska-Curie Memorial Cancer Center
🇵🇱Warsaw, Poland
Fondazione IRCCS Istituto Nazionale Dei Tumori
🇮🇹Milan, Italy
Regina Elena National Cancer Institute
🇮🇹Rome, Italy
University of Colorado - Denver
🇺🇸Denver, Colorado, United States
University of Miami
🇺🇸Miami, Florida, United States
Dana Farber
🇺🇸Boston, Massachusetts, United States
OHSU
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Istituto Nazionale dei Tumori
🇮🇹Milan, Italy
University College Hospital
🇬🇧London, United Kingdom
Hospital Universitario Virgen del RocÃo, Sevilla
🇪🇸Sevilla, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain