Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: IPI-504
  • IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: IPI-504
  • IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment

Primary 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
    Safety Issue?: No

Secondary Measures

• To determine the clinical benefit rate and duration of overall response
  • Time Frame: Every 6 weeks
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Infinity Pharmaceuticals

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00969917

Study ID Number: IPI-504-09

ClinicalTrials.gov Identifier: NCT00969917

Health Authority: United States: Food and Drug Administration