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

This study has been withdrawn prior to enrollment.

( Company decision not to start the study )

First Received on September 1, 2009. Last Updated on June 6, 2011 History of Changes

Sponsor:	Infinity Pharmaceuticals, Inc.
Information provided by:	Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00969917

Purpose

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.

Condition	Intervention	Phase
Dedifferentiated Liposarcoma	Drug: IPI-504	Phase II

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

Resource links provided by NLM:

Drug Information available for: 17-(Allylamino)-17-demethoxygeldanamycin IPI-504

U.S. FDA Resources

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

Primary Outcome Measures:

To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the clinical benefit rate and duration of overall response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969917

Locations

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

Sponsors and Collaborators

Infinity Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Eduardo Rodenas, MD, Infinity Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00969917 History of Changes
Other Study ID Numbers:	IPI-504-09
Study First Received:	September 1, 2009
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on February 08, 2012