A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of IPI-493 in Patients Experiencing Advanced Hematologic Malignancies With Client Proteins of Hsp90
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of Safety Endpoints
Safety Endpoints The incidence of reported adverse events (AEs), serious adverse events (SAEs), concomitant medication use, laboratory test results, electrocardiogram (ECG) results, Eastern Cooperative Oncology Group (ECOG) performance status results, and vital sign results Maximum tolerated dose, defined as the dose level below the dose at which ≥33% of patients experience a dose limiting toxicity (DLT) Pharmacodynamic Endpoints
Robert Ross, M.D.
Infinity Pharmaceuticals, Inc.
United States: Food and Drug Administration
|M.D. Anderson Cancer Center||Houston, Texas 77030|
|Weill Cornell Cancer Center||New York, New York 10065|
|Johns Hopkins Sidney Kimmel Cancer Center||Baltimore, Maryland 21201|