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Thiazolidinedione

efatutazone for Liposarcoma

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will test if efatutazone dihydrochloride can help treat patients with myxoid liposarcoma that has come back or spread.

Eligible Conditions
  • Liposarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Overall Response Rate Per the RECIST 1.1 Criteria
Secondary outcome measures
Incidence of Grade 3+ Adverse Events Summarized Using Common Terminology Criteria for Adverse Events Version 4.0
Overall Survival
Progression Free Survival (PFS) Determined Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Side effects data

From 2023 Phase 2 trial • 19 Patients • NCT02152137
80%
Anemia
67%
Edema limbs
67%
Peripheral sensory neuropathy
60%
Weight gain
60%
Fatigue
40%
Pleural effusion
40%
White blood cell decreased
40%
Neutrophil count decreased
33%
Lymphocyte count decreased
33%
Nausea
27%
Alopecia
27%
Dyspnea
27%
Hypertriglyceridemia
20%
Anorexia
20%
Creatinine increased
20%
Dry mouth
20%
Diarrhea
20%
Platelet count decreased
20%
Hyponatremia
13%
Edema face
13%
Cholesterol high
13%
Blood bilirubin increased
13%
Tracheostomy site bleeding
13%
Stridor
13%
Constipation
13%
Vomiting
13%
Myalgia
13%
Arthralgia
13%
Hypertension
13%
Skin and subcut tissue disord - Oth spec
13%
Paresthesia
7%
Alanine aminotransferase increased
7%
Dysgeusia
7%
Infections and infestations - Oth spec
7%
Hypoalbuminemia
7%
Mucositis oral
7%
Dizziness
7%
Hypotension
7%
Aspartate aminotransferase increased
7%
Neck edema
7%
Gastric hemorrhage
7%
Anaphylaxis
7%
Hypoxia
7%
Superior vena cava syndrome
7%
Blood and lymph sys disorders - Oth Spec
7%
Dysphagia
7%
Death NOS
7%
Bloating
7%
Investigations - Other, specify
7%
Tinnitus
7%
Chills
7%
Pulmonary edema
7%
Hypothyroidism
7%
Sinus tachycardia
7%
Gastrointestinal disorders - Oth spec
7%
Pericardial effusion
7%
Gastroesophageal reflux disease
7%
Dry eye
7%
Non-cardiac chest pain
7%
Hypermagnesemia
7%
Fever
7%
Urinary tract infection
7%
Hypomagnesemia
7%
Dehydration
7%
Hyperglycemia
7%
Rash acneiform
7%
Nervous system disorders - Oth spec
7%
Pruritus
7%
Scalp pain
7%
Hypokalemia
7%
Anxiety
7%
Productive cough
7%
Muscle weakness lower limb
7%
Bone pain
7%
Dry skin
7%
Generalized muscle weakness
7%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Efatutazone Dihydrochloride, Paclitaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: efatutazone dihydrochlorideExperimental Treatment1 Intervention
Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efatutazone
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
392 Previous Clinical Trials
411,350 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
415,282 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,257 Total Patients Enrolled
28 Trials studying Liposarcoma
2,128 Patients Enrolled for Liposarcoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects has efatutazone been associated with?

"Our team at Power assigned efatutazone a score of 2, due to the Phase 2 trial status that implies some evidence for safety but no research on efficacy."

Answered by AI

What is the precedent for utilizing efatutazone in clinical trials?

"Currently, two studies are underway investigating efatutazone. Neither of these trials is in their final stage yet. While the main site for research on this medication is located in Peoria, Illinois, 380 other locations have also launched clinical trials with efatutazone as a potential treatment option."

Answered by AI

Are there any current opportunities for participants in this medical experiment?

"As reported via clinicaltrials.gov, this medical trial has concluded its recruitment process and is no longer actively seeking participants. Initially posted on October 1st 2014, the last update occurred on August 16th 2021. However, there are still 46 other trials currently enrolling patients for evaluation."

Answered by AI

Is this a pioneering clinical trial?

"Since 2014, Daiichi Sankyo has sponsored research into efatutazone. This began with a Phase 1 trial involving 19 patients and culminated in the drug being approved for use during its second stage of testing. Currently, two active studies are running across 224 cities and one nation."

Answered by AI

How many participants are being incorporated into this investigation?

"Unfortunately, the recruitment period for this clinical trial has lapsed. It was first posted on October 1st 2014 and last edited August 16th 2021. For individuals who are still seeking a medical study to join, there are currently 44 trials that require patients with liposarcoma and 2 studies involving efatutazone actively recruiting participants."

Answered by AI

How many locations are presently hosting this research project?

"This extensive research project is currently taking place in over a hundred locations, with notable sites located in Maywood, Oklahoma City and Mattoon. To minimize the need to travel if you join the study it is best to choose an available site near your home location."

Answered by AI
~1 spots leftby Apr 2025