Dose Escalation of IPI-493 in Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193491
Recruitment Status : Terminated (Drug exposure of retaspimycin HCl was superior to IPI-493, Infinity will focus on Retaspimycin HCL)
First Posted : September 2, 2010
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: IPI-493 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: IPI-493 Drug: IPI-493
Capsules, ascending dose, multiple schedules
Other Names:
  • HSP-90
  • Geldanamycin

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Evaluation of Efficacy Endpoints [ Time Frame: 1 year ]
  2. Evaluation of Efficacy Endpoints [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >/=18 years old
  • ECOG 0-1
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01193491

United States, Maryland
Johns Hopkins Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21201
United States, New York
Weill Cornell Cancer Center
New York, New York, United States, 10065
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Study Director: Robert Ross, M.D. Infinity Pharmaceuticals, Inc.

Responsible Party: Infinity Pharmaceuticals, Inc. Identifier: NCT01193491     History of Changes
Other Study ID Numbers: IPI-493-02
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Infinity Pharmaceuticals, Inc.:
Phase 1
Client Proteins

Additional relevant MeSH terms: