Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That … (NCT02249949) | Clinical Trial Compass
CompletedPhase 2
Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
United States15 participantsStarted 2015-02-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 n…
What they're measuring
1
Confirmed Overall Response Rate Per the RECIST 1.1 Criteria