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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This study has been withdrawn prior to enrollment.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
  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 2

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

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 June 18, 2013