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

NCT00969917 | Withdrawn Phase 2

• 1 other identifier: IPI-504-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dedifferentiated Liposarcoma

Outcome Measures

Primary Outcomes (1)

• To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.

  Every 6 weeks

Secondary Outcomes (1)

• To determine the clinical benefit rate and duration of overall response

  Every 6 weeks

Study Arms (1)

IPI-504

EXPERIMENTAL

IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment

Drug: IPI-504

Interventions

IPI-504 DRUG

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

IPI-504

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Infinity Pharmaceuticals, Inc.: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Liposarcoma

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)