Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT02152137|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : May 29, 2019
|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|
|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 5 years ]
- Overall Survival [ Time Frame: Time from study entry to death from any cause, assessed up to 12 months of follow-up ]
- 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 ]
- 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 ]
- Incidence of adverse events summarized using CTCAE version 4.0 [ Time Frame: Up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152137
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|Study Chair:||Robert Smallridge, M.D.||Mayo Clinic|