Phase 2
N=13
Efatutazone Dihydrochloride in Treating Patients With Previously Treated Myxoid Liposarcoma That Cannot Be Removed by Surgery
Liposarcoma
Bottom Line
View on ClinicalTrials.gov: NCT02249949 ↗Enrolled (actual)
13
Serious AEs
54.6%
Results posted
Jun 2019
Primary outcome: Primary: Confirmed Overall Response Rate Per the RECIST 1.1 Criteria — 0 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- efatutazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Overall Response Rate Per the RECIST 1.1 Criteria |
— | — |
| SECONDARY Progression Free Survival (PFS) Determined Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
1.4 | — |
| SECONDARY Overall Survival |
8.6 | — |
| SECONDARY Incidence of Grade 3+ Adverse Events Summarized Using Common Terminology Criteria for Adverse Events Version 4.0 |
6; 3 | — |
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.
Eligibility Criteria
- 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 = = 1,000/mm^3
- Platelet count >= 75,000/mm^3
- Creatinine = = 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
Data sourced from ClinicalTrials.gov (NCT02249949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.