Status:
COMPLETED
Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Daiichi Sankyo
Conditions:
Liposarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, su...
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...
Eligibility Criteria
Inclusion
- Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H\&E) and 20 unstained myxoid liposarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
- Measurable disease
- Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment
- There is no limit to the number of prior lines of treatment a patient has received
- No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =\< 28 days before study registration; no treatment with nitrosourea or mitomycin =\< 42 days before study registration
- Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 or less
- No history of the following:
- Class III or IV congestive heart failure (CHF)
- Pericardial effusion =\< 12 months (grade 3 or 4)
- Pericardial involvement with tumor
- Grade 2 or higher pleural effusion =\< 6 months
- No symptomatic, untreated, or uncontrolled brain metastases present
- Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required; a female of childbearing potential is a sexually mature female who:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible
- Patients with known hypersensitivity to any TZD oral agents are not eligible
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- Platelet count \>= 75,000/mm\^3
- Creatinine =\< 1.5 mg/dL x upper limits of normal (ULN) OR calculated (calc.) creatinine clearance \>= 30 mL/min
- Bilirubin =\< 1.5 x ULN; for subjects with liver metastases =\< 3 x ULN is allowed
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN; for subjects with liver metastases, SGOT (AST) and SGPT (ALT) \< 5 x the upper normal limit of institution's normal range is allowed
- Eligible patients must have histopathologically confirmed myxoid liposarcoma with confirmation of DDIT3 rearrangement
Exclusion
Key Trial Info
Start Date :
February 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02249949
Start Date
February 11 2015
End Date
May 1 2023
Last Update
January 27 2025
Active Locations (127)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06520
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007