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This study has been withdrawn prior to enrollment.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

September 1, 2009
June 6, 2011
January 2010
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00969917 on ClinicalTrials.gov Archive Site
To determine the clinical benefit rate and duration of overall response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dedifferentiated Liposarcoma
Drug: IPI-504
IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
Experimental: IPI-504
IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment
Intervention: Drug: IPI-504
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00969917
IPI-504-09
No
Eduardo Rodenas, MD, Infinity Pharmaceuticals
Infinity Pharmaceuticals, Inc.
Not Provided
Not Provided
Infinity Pharmaceuticals, Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP