Status:
WITHDRAWN
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
Lead Sponsor:
Infinity Pharmaceuticals, Inc.
Conditions:
Dedifferentiated Liposarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00969917
Start Date
January 1 2010
End Date
December 1 2010
Last Update
April 14 2015
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115