NCT02249949

Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery

A Phase II Study of the Peroxisome Proliferator-Activated Receptor Gamma Agonist, Efatutazone in Patients With Previously Treated, Unresectable Myxoid Liposarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well efatutazone dihydrochloride works in treating patients with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To determine the confirmed response rate for efatutazone dihydrochloride (efatutazone) in patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy. SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS), overall survival (OS), and adverse event rates for efatutazone treated patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy. TERTIARY OBJECTIVES: I. To assess the predictive value of peroxisome proliferator-activated receptor (PPAR) and retinoid X receptors (RXR) tumor expression from archived patient tumor samples. II. To assess the predictive value of the expression of PPARgamma-regulated markers of adipocytes differentiation. III. To assess the predictive value of the expression of PPARgamma-regulated cell cycle proteins. IV. To assess the effects of efatutazone treatment on serum adiponectin levels. OUTLINE: Patients receive efatutazone dihydrochloride orally (PO) twice daily (BID) continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 6 months for up to 5 years.

Conditions

• Liposarcoma

Interventions

Type	Name	Description
DRUG	efatutazone	Given PO

Timeline

• Start date: 2015-02-11
• Primary completion: 2018-10-04
• Completion: 2023-05-01
• First posted: 2014-09-26
• Last updated: 2025-01-27
• Results posted: 2019-06-27

Locations

127 sites across 1 country: United States