Phase 1/2 Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523, an ERK 1/2 Inhibitor, in Patients With Advanced Malignancies
The study is being performed to assess the safety and tolerability of BVD-523 given orally,
twice daily for 21-day cycles.
In Part 1 of the study, an accelerated dose escalation plan will be used to establish dose
limiting toxicities (DLT), maximum tolerated dose (MTD), and the recommended Phase 2 dose
(RP2D).
In Part 2 of the study, additional patients with particular tumor types and/or cancers
harboring specific genetic mutations will be recruited for treatment at the Recommended
Phase 2 Dose (RP2D). Patients may also be assessed pharmacodynamic measures in healthy or
malignant tissues, using biomarker assays for phosphorylation, cytotoxic or cytostatic
measures.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of recommended phase 2 dose (RP2D) of BVD-523 determined by dose-limiting toxicities.
Until safety and tolerability limit further dose escalation; up to ~18 months
Yes
United States: Food and Drug Administration
BVD-523-01
NCT01781429
March 2013
March 2015
Name | Location |
---|---|
Massachusetts General Hospital (MGH) | Boston, Massachusetts 02114 |
UCLA Med-Hematology & Oncology | Los Angeles, California 90095 |
Sarah Cannon Research Institute/Yale Cancer Center | New Haven, Connecticut 06520 |
Florida Cancer Specialists and Research Group (Sarah Cannon Research Institute) | Sarasota, Florida 34232 |
Sarah Cannon Research Institute Hospital at Vanderbilt | Nashville, Tennessee 37203 |