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

NCT ID: NCT00969917

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dedifferentiated Liposarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IPI-504

IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment

Group Type EXPERIMENTAL

IPI-504

Intervention Type DRUG

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

Interventions

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IPI-504

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Infinity Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Infinity Pharmaceuticals

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IPI-504-09

Identifier Type: -

Identifier Source: org_study_id

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