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

Infinity Pharmaceuticals, Inc.3 sites in 1 country4 target enrollmentJune 2010

ConditionsHematologic Malignancies

InterventionsIPI-493

DrugsIPI-493

Overview

Phase: Phase 1
Intervention: IPI-493
Conditions: Hematologic Malignancies
Sponsor: Infinity Pharmaceuticals, Inc.
Enrollment: 4
Locations: 3
Primary Endpoint: Evaluation of Safety Endpoints
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

July 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Infinity Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\>/=18 years old
•confirmed hematological malignancy
•refractory to available therapy or for which no therapy is available
•adequate hepatic, renal function

Exclusion Criteria

•active CNS malignancy
•prolonged QT interval
•significant GI/liver disease
•other serious concurrent illness or medical condition

Arms & Interventions

IPI-493

Intervention: IPI-493

Outcomes

Primary Outcomes

Evaluation of Safety Endpoints

Time Frame: 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