Dose Escalation of IPI-493 in Hematologic Malignancies

April 14, 2015 updated by: Infinity Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Johns Hopkins Sidney Kimmel Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Efficacy Endpoints
Time Frame: 1 year
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinity Pharmaceuticals, Inc.

Investigators

  • Study Director: Robert Ross, M.D., Infinity Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-493-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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