Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT02152137|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Results First Posted : December 27, 2019
Last Update Posted : August 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Thyroid Cancer Recurrent Thyroid Cancer||Drug: efatutazone Drug: paclitaxel||Phase 2|
I. To determine if the combination of paclitaxel and efatutazone (efatutazone dihydrochloride) improves the confirmed response rate in patients with advanced anaplastic thyroid cancer.
I. To estimate the overall survival (OS), duration of response, progression-free survival (PFS), and adverse event rates for the combination of paclitaxel and efatutazone.
I. The association of biomarkers with clinical outcome data will be assessed in an exploratory translational analysis.
Patients receive paclitaxel intravenously (IV) over 3 hours on day 1 and efatutazone dihydrochloride orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 28 days, every 8 weeks until disease progression, and then every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination With Paclitaxel in Patients With Advanced Anaplastic Thyroid Cancer|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 27, 2019|
Experimental: efatutazone dihydrochloride, paclitaxel
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.
Other Name: CS-7017
Other Name: Taxol
- Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria [ Time Frame: Up to 24 weeks ]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.
- Overall Survival [ Time Frame: Time from study entry to death from any cause, assessed up to 5 years ]Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
- Duration of Confirmed Response [ Time Frame: The time from the first documented date of confirmed response (CR or PR) to date at which progression is first documented, assessed up to 5 years ]Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
- PFS Determined Based on RECIST 1.1 Criteria [ Time Frame: The time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years ]Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0 [ Time Frame: Up to 5 years ]The number of patients who experienced at least one grade 3 or higher adverse event is reported below.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152137
|Study Chair:||Robert Smallridge, M.D.||Mayo Clinic|