The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and schedule of IPI-493 in patients with hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Capsules, ascending dose, multiple schedules
Johns Hopkins Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Weill Cornell Cancer Center
New York, New York, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
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
Time frame: 1 year
Evaluation of Efficacy Endpoints
Time frame: 1 year
Evaluation of Efficacy Endpoints
* Hematologic disease-specific outcomes for response including but not limited to complete hematologic response (CHR) and partial hematologic response (PHR) * Plasma concentrations of IPI-493 (and IPI-493 metabolites, if applicable)
Time frame: 1 year
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