NCT02249949|CompletedPhase 2ResultsDMC

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

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A091202NCI-2014-01028

Study Type

interventional

Target

Locations

1 country

Sites

127

Timeline

RegisteredSep 2014

StartedFeb 2015

CompletionMay 2023

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Feb 2015

Longer than P75 for phase_2

Geographic Reach

1 country

127 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.2 years study duration

First Submitted

Initial submission to the registry

September 24, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

February 11, 2015

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2018

Completed

9 months until next milestone

Results Posted

Study results publicly available

June 27, 2019

Completed

3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

3.6 years

First QC Date

September 24, 2014

Results QC Date

June 10, 2019

Last Update Submit

January 14, 2025

Conditions

Liposarcoma

Outcome Measures

Primary Outcomes (1)

Confirmed Overall Response Rate Per the RECIST 1.1 Criteria
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.
Up to 24 weeks (8 cycles)

Secondary Outcomes (3)

Progression Free Survival (PFS) Determined Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years
Overall Survival
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
Up to 5 years

Study Arms (1)

efatutazone dihydrochloride

EXPERIMENTAL

Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: efatutazone

Interventions

efatutazoneDRUG

Given PO

efatutazone dihydrochloride

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator
Daiichi Sankyocollaborator

Study Sites (127)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Northside Hospital-Forsyth

Cumming, Georgia, 30041, United States

Location

Hawaii Cancer Care Inc-POB II