Dose Escalation of IPI-493 in Hematologic Malignancies
- Registration Number
- NCT01193491
- Lead Sponsor
- Infinity Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- >/=18 years old
- ECOG 0-1
- confirmed hematological malignancy
- refractory to available therapy or for which no therapy is available
- adequate hepatic, renal function
- active CNS malignancy
- prolonged QT interval
- significant GI/liver disease
- other serious concurrent illness or medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IPI-493 IPI-493 -
- Primary Outcome Measures
Name Time Method Evaluation of Safety Endpoints 1 year 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
- Secondary Outcome Measures
Name Time Method Evaluation of Efficacy Endpoints 1 year * 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)
Trial Locations
- Locations (3)
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