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

• Status: Withdrawn
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.

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.