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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome: Confirmed response rate per the RECIST 1.1 criteria [ Time Frame: Up to 4 years ]

Original Primary Outcome: Progression Free Survival [ Time Frame: 5 years post-study treatment ]

Current Secondary Outcome:

  • PFS determined based on RECIST 1.1 [ Time Frame: Time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years ]
  • Overall survival [ Time Frame: Time from study entry to death from any cause, assessed up to 5 years ]
  • Incidence of grade 3+ adverse events summarized using Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Confirmed response rate [ Time Frame: Up to 5 years post-study treatment ]
  • Overall survival [ Time Frame: Up to 5 years post-study treatment ]
  • Frequency and percentage of adverse events of grade 3+ according to Common Terminology Criteria for Adverse Events [ Time Frame: Up to 5 years post-study treatment ]


Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: September 24, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 19, 2017
Last Verified: April 2017