Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

April 13, 2015 updated by: Infinity Pharmaceuticals, Inc.

A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute

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:

  • At least 18 years of age at the time of signing informed consent.
  • Histologic diagnosis of dedifferentiated liposarcoma.
  • Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
  • At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
  • No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
  • Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
  • Life expectancy ≥6 months.

Exclusion Criteria:

  • Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.
  • Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
  • Patients with prior hepatic resections or hepatic-directed therapy
  • Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.

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-504
IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment
Drug: IPI-504
IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
Time Frame: Every 6 weeks
Every 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the clinical benefit rate and duration of overall response
Time Frame: Every 6 weeks
Every 6 weeks

Collaborators and Investigators

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

Sponsor

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

January 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion

December 1, 2010

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-504-09

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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