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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)
Sponsor:
Information provided by:
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01193491
First received: June 28, 2010
Last updated: June 10, 2011
Last verified: August 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Evaluation of Safety Endpoints [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
  • Evaluation of Efficacy Endpoints [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • 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
Estimated Study Completion Date: July 2011
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193491

Locations
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.
Investigators
Study Director: Robert Ross, M.D. Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Rob Ross M.D., Medical Director, Infinity Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01193491     History of Changes
Other Study ID Numbers: IPI-493-02
Study First Received: June 28, 2010
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
Phase 1
AML
CML
 MPD
Client Proteins
Hsp90

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Geldanamycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cysteine Proteinase Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013