Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
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ClinicalTrials.gov Identifier: NCT02249949 |
Recruitment Status :
Active, not recruiting
First Posted : September 26, 2014
Results First Posted : June 27, 2019
Last Update Posted : July 24, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | September 24, 2014 | |||
First Posted Date ICMJE | September 26, 2014 | |||
Results First Submitted Date ICMJE | June 10, 2019 | |||
Results First Posted Date ICMJE | June 27, 2019 | |||
Last Update Posted Date | July 24, 2020 | |||
Actual Study Start Date ICMJE | October 2014 | |||
Actual Primary Completion Date | October 4, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Confirmed Overall Response Rate Per the RECIST 1.1 Criteria [ Time Frame: Up to 24 weeks (8 cycles) ] The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
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Original Primary Outcome Measures ICMJE |
Progression Free Survival [ Time Frame: 5 years post-study treatment ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery | |||
Official Title ICMJE | 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 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Liposarcoma | |||
Intervention ICMJE | Drug: efatutazone
Given PO
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Study Arms ICMJE | Experimental: efatutazone dihydrochloride
Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: efatutazone
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
15 | |||
Original Estimated Enrollment ICMJE |
36 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | October 4, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02249949 | |||
Other Study ID Numbers ICMJE | A091202 NCI-2014-01028 ( Registry Identifier: NCI Clinical Trials Reporting Program ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Alliance for Clinical Trials in Oncology | |||
Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | July 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |