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

Phase 2

Withdrawn

• Conditions: Dedifferentiated Liposarcoma
• Interventions: Drug: IPI-504

• Registration Number: NCT00969917
• Lead Sponsor: Infinity Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPI-504	IPI-504	IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment

Primary Outcome Measures

Name	Time	Method
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.	Every 6 weeks

Secondary Outcome Measures

Name	Time	Method
To determine the clinical benefit rate and duration of overall response	Every 6 weeks

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States