Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor (NCT03069469) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
United States120 participantsStarted 2017-02-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients ≥18 years of age
✓. Patients must have:
✓. advanced malignant solid tumors; or
✓. symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
✓. Malignant solid tumor patients only: Able to provide a tumor tissue sample
✓. Must have 1 measurable lesion according to RECIST Version 1.1
✓. Malignant solid tumor patients only: Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
✓. Adequate organ and bone marrow function
Exclusion criteria
✕. 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.
✕. Unresolved toxicity (Grade \>1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia.
✕. Known active central nervous system (CNS) metastases.
✕. History or presence of clinically relevant cardiovascular abnormalities.
✕
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: Day 1 - Day 28 of Cycle 1 for each dose level tested
2
Number of Patients with Dose-Limiting Toxicities (DLTs)
Timeframe: Day 1- Day 28 of Cycle 1 for each dose level tested
3
Time to maximum observed concentration of Vimseltinib
Timeframe: 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)
4
Maximum observed concentration of Vimseltinib
Timeframe: 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)
5
Trough observed concentration of Vimseltinib
Timeframe: 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)
6
Area under the concentration-time curve (AUC) of Vimseltinib
Timeframe: 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)
7
Half life of Vimseltinib
Timeframe: 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)