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This study has been withdrawn prior to enrollment.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)

Sponsor:

Information provided by:

Infinity Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00969917

First received: September 1, 2009

Last updated: June 6, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 1, 2009
Last Updated Date	June 6, 2011
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 1, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00969917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 1, 2009)	To determine the clinical benefit rate and duration of overall response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
Official Title ^ICMJE	A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
Brief Summary	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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Dedifferentiated Liposarcoma
Intervention ^ICMJE	Drug: IPI-504 IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
Study Arm (s)	Experimental: IPI-504 IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment Intervention: Drug: IPI-504
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	40
Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00969917
Other Study ID Numbers ^ICMJE	IPI-504-09
Has Data Monitoring Committee	No
Responsible Party	Eduardo Rodenas, MD, Infinity Pharmaceuticals
Study Sponsor ^ICMJE	Infinity Pharmaceuticals, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Infinity Pharmaceuticals, Inc.
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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