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

Dedifferentiated Liposarcoma Clinical Trial

Official title:

A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00969917
• Other study ID #: IPI-504-09
• Status: Withdrawn
• Phase: Phase 2
• First received: September 1, 2009
• Last updated: April 13, 2015
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dedifferentiated Liposarcoma
• Liposarcoma

Intervention

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

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.		Every 6 weeks	No
Secondary	To determine the clinical benefit rate and duration of overall response		Every 6 weeks	No