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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Colony-stimulating factor 1 receptor (CSF1R) inhibitor
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
...and 14 more locations
Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose.
Time frame: Day 1 - Day 28 of Cycle 1 for each dose level tested
Number of Patients with Dose-Limiting Toxicities (DLTs)
Identify the number of patients with DLTs for each dose level tested.
Time frame: Day 1- Day 28 of Cycle 1 for each dose level tested
Time to maximum observed concentration of Vimseltinib
Measure the time to maximum plasma concentration of vimseltinib in patients.
Time frame: 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)
Maximum observed concentration of Vimseltinib
Measure the maximum observed concentration of vimseltinib in patients.
Time frame: 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)
Trough observed concentration of Vimseltinib
Measure the observed trough concentration of vimseltinib in patients.
Time frame: 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)
Area under the concentration-time curve (AUC) of Vimseltinib
Measure the AUC of vimseltinib.
Time frame: 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)
Half life of Vimseltinib
Measure half life of vimseltinib in patients.
Time frame: 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)
Objective response rate (ORR= complete response [CR]+partial response [PR]) (Expansion Phase only)
Assessed by central read using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Time frame: At Week 25 (Cycle 7, Day 1)
Duration of response rate (DOR) (Expansion Phase only)
Measure time from partial response (PR) or complete response (CR) to disease progression or death.
Time frame: Date from PR or CR to disease progression or death (Estimated up to 24 months)
Response rate (Expansion Phase only)
Assessed by central read using tumor volume score and modified RECIST (mRECIST) Version 1.1
Time frame: At Week 25 (Cycle 7, Day 1)
Range of Motion (ROM) (Expansion Phase only)
Measure mean change from baseline in relative ROM
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale (NRS) Score (Expansion Phase only)
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)
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score (Expansion Phase only)
Analysis of patient reported outcomes based upon the patient-reported outcomes measurement information system (PROMIS) physical function questionnaire
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Worst Stiffness Numeric Rating Scale (NRS) Score (Expansion Phase only)
Analysis of patient reported outcomes based upon the Worst Stiffness Numeric Rating Scale (NRS)
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
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