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Thiazolidinedione

paclitaxel for Thyroid Cancer

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
There is no limit to the number of prior lines of treatment a patient has received
No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will study how well efatutazone dihydrochloride and paclitaxel work in treating patients with advanced anaplastic thyroid cancer.

Eligible Conditions
  • Thyroid Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The number of treatments you received in the past does not affect your eligibility.
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You have not received chemotherapy, radiation therapy, immunotherapy, or other types of treatment for at least 21 days prior to enrolling in the study.
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You have a mental health condition that would make it difficult for you to understand and make decisions about the study.
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You have uncontrolled infections like HIV, uncontrolled diabetes, or heart disease that make participating in the study too risky, according to your doctor.
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You are unable to swallow the study medication in pill form.
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You have cancer that has either spread to other parts of your body or is too advanced to be removed by surgery.

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
Heart rate
Secondary outcome measures
Duration of Confirmed Response
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
Overall Survival
+1 more

Side effects data

From 2008 Phase 2 trial • 149 Patients • NCT02004093
59%
Nausea
59%
Diarrhoea
48%
Neutropenia
40%
Fatigue
32%
Vomiting
29%
Alopecia
27%
Constipation
25%
Decreased appetite
25%
Anaemia
24%
Abdominal pain
23%
Rash
21%
Headache
19%
Epistaxis
15%
Drug hypersensitivity
15%
Arthralgia
15%
Thrombocytopenia
15%
Neuropathy peripheral
13%
Dysgeusia
13%
Stomatitis
12%
Dizziness
12%
Dyspepsia
12%
Leukopenia
12%
Asthenia
11%
Dyspnoea
11%
Nail disorder
11%
Peripheral sensory neuropathy
9%
Mucosal inflammation
9%
Pruritus
9%
Muscle spasms
9%
Cystitis
8%
Hemorrhoids
8%
Insomnia
8%
Back pain
8%
Hypertension
8%
Pain in extremity
8%
Urinary tract infection
7%
Nasopharyngitis
7%
Cough
7%
Bone pain
7%
Erythema
7%
Flushing
7%
Myalgia
7%
Abdominal pain upper
7%
Pyrexia
7%
Chest pain
7%
Musculoskeletal pain
5%
Lethargy
5%
Dry skin
5%
Paraesthesia
5%
Abdominal pain lower
5%
Vaginal discharge
5%
Oedema peripheral
4%
Phlebitis
3%
Intestinal obstruction
1%
Abdominal distension
1%
Ascites
1%
Local swelling
1%
Pulmonary embolism
1%
Diaphragmatic hernia
1%
Cardiac failure congestive
1%
Hepatic lesion
1%
Blood glucose increased
1%
Gastrointestinal haemorrhage
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Syncope
1%
Ileus paralytic
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy + Pertuzumab
Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: efatutazone dihydrochloride, paclitaxelExperimental Treatment2 Interventions
Patients receive paclitaxel IV over 3 hours on day 1 and efatutazone dihydrochloride PO BID on days 1-21. 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
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,615 Previous Clinical Trials
40,918,678 Total Patients Enrolled
Daiichi SankyoIndustry Sponsor
388 Previous Clinical Trials
409,637 Total Patients Enrolled
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
415,235 Total Patients Enrolled

Frequently Asked Questions

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

What therapeutic applications is paclitaxel commonly employed for?

"Paclitaxel is frequently utilized to manage neoplasm metastasis, as well as Kaposi sarcoma, advanced directives, and fallopian tubes cancer."

Answered by AI

How many individuals have enrolled in this experiment?

"This clinical trial has finished enrolling patients. It was initially posted in September 2014 and the last update occurred on August 16th 2021. There are a plethora of other trials actively recruiting; 229 for thyroid cancer, anaplastic, and 833 for paclitaxel specifically."

Answered by AI

Have other medical studies explored the efficacy of paclitaxel?

"Currently, 833 medical trials that research paclitaxel are ongoing and 227 of them have reached the 3rd stage. Most trails regarding this drug take place in Melbourne, Victoria yet there is a total of 45766 different sites conducting tests for it."

Answered by AI

Does this research offer opportunities for patient involvement?

"At present, this clinical trial is not accepting new participants. As indicated on the clinicaltrials.gov website, it was first posted in September 2014 and most recently updated in August 2021. Fortunately, there are 1062 other studies actively recruiting patients at this time."

Answered by AI

How many medical facilities are currently offering this trial?

"This trial is running at 103 sites, including Macomb Hematology Oncology PC in Warren, Michigan, Hawaii Cancer Care Inc-Liliha in Honolulu, Hawaii, and Cancer Center of Kansas - El Dorado in El Dorado."

Answered by AI

Has paclitaxel been granted permission to be used in approved treatments by the FDA?

"Paclitaxel was assigned a score of 2 due to the lack of evidence supporting its efficacy, though there is data indicating it has some safety."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Providence Saint Joseph Medical Center/Disney Family Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Mar 2025