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Dose Escalation of IPI-493 in Hematologic Malignancies

This study has been terminated.
(Drug exposure of retaspimycin HCl was superior to IPI-493, Infinity will focus on Retaspimycin HCL)
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc. Identifier:
First received: June 28, 2010
Last updated: April 14, 2015
Last verified: April 2015
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 Intervention Phase
Hematologic Malignancies
Drug: IPI-493
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • Evaluation of Efficacy Endpoints [ Time Frame: 1 year ]
  • 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)

Enrollment: 4
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-493 Drug: IPI-493
Capsules, ascending dose, multiple schedules
Other Names:
  • HSP-90
  • Geldanamycin


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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.
  More Information

Responsible Party: Infinity Pharmaceuticals, Inc. Identifier: NCT01193491     History of Changes
Other Study ID Numbers: IPI-493-02
Study First Received: June 28, 2010
Last Updated: April 14, 2015

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

Additional relevant MeSH terms:
Neoplasms processed this record on March 29, 2017