A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Dose Limiting Toxicities (DLT)
Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 unless otherwise specified. A DLT is defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days following the first dose of BYL719 and MEK162 (Cycle 1), and meets any of the protocol-specified DLT criteria.
during the first cycle (28 days) of treatment with BYL719 and MEK162
United States: Food and Drug Administration
|Massachusetts General Hospital CCPO||Boston, Massachusetts 02114|
|University of Utah / Huntsman Cancer Institute Huntsman (3)||Salt Lake City, Utah 84103|