Sutent Adjunctive Treatment of Differentiated Thyroid Cancer
IIT Sutent
Sponsor study identifier
interventional
23
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
December 2015
Actual (reported)This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed. This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 25, 2008
Actual (reported)April 29, 2008
Actual (reported)September 2015
Actual (reported)December 2015
Actual (reported)April 18, 2018
Actual (reported)Progression Free Survival
Progressive disease (PD) is defined as unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions. Disease progression is accessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
12 months after last patient completes treatment
Overall Survival
12 months after last patient completes treatment
Sutent 37.5 mg/day will be given orally.
Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Britten CD, Kabbinavar F, Hecht JR, Bello CL, Li J, Baum C, Slamon D. A phase I and pharmacokinetic study of sunitinib administered daily for 2 weeks, followed by a 1-week off period. Cancer Chemother Pharmacol. 2008 Mar;61(3):515-24. doi: 10.1007/s00280-007-0498-4. Epub 2007 May 16.
Bikas A, Kundra P, Desale S, Mete M, O'Keefe K, Clark BG, Wray L, Gandhi R, Barett C, Jelinek JS, Wexler JA, Wartofsky L, Burman KD. Phase 2 clinical trial of sunitinib as adjunctive treatment in patients with advanced differentiated thyroid cancer. Eur J Endocrinol. 2016 Mar;174(3):373-80. doi: 10.1530/EJE-15-0930. Epub 2015 Dec 15.
Kenneth D Burman, MD
Medstar Health Research Institute
23 participants (actual enrollment reported by the registry).
First Submitted
April 25, 2008
First Posted
April 29, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
[18F]Tetrafluoroborate PET/CT for the Detection of Differentiated Thyroid Cancer: A Phase II Imaging Study
Contact the study team to confirm eligibility.
Primary Completion
September 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
August 5, 2020
Results First Posted
April 18, 2018
Record last verified: 2020-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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