Trial Condition(s):
Thyroid Neoplasms
Nexavar® versus Placebo in locally advanced/metastatic RAI-Refractory Differentiated Thyroid Cancer
Bayer Identifier:
14295
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine
Inclusion Criteria
- Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell) - Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features - Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression) - RAI (radioactive iodine) refractory
Exclusion Criteria
- Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma) - Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents - Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cardiff, United Kingdom, CF14 2TL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Haven, United States, 06520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213-1863 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Würzburg, Germany, 97080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SM2 5PT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE1 9RT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98109-1023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stanford, United States, 94305-5820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30322 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BORDEAUX, France, 33076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF, France, 94805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON, France, 69373 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 60-355 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Siena, Italy, 53100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Catania, Italy, 95029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CAEN, France, 14076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE cedex, France, 13273 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANGERS, France, 49933 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE cedex, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gliwice, Poland, 44-101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashiwa, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 464-8681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Odense C, Denmark, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riyadh, Saudi Arabia, 11211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daejeon, South Korea, 301-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site hangzhou, China, 310022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site shanghai, China, 200127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Obninsk, Russia, 249036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sutton, United Kingdom, SM2 5PT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aberdeen, United Kingdom, AB25 2ZN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glasgow, United Kingdom, G12 0YN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression-free survival (PFS) based on central assessment incl. clinical progression due to bone irradiationTimeframe: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
Secondary Outcome
- Overall survival (OS)Timeframe: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eighty ears
- Time to progression (TTP) based on central assessment incl. clinical progression due to bone irradiationTimeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
- Disease control rate (DCR) based on central assessment incl. clinical progression due to bone irradiationTimeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
- Response rate based on central assessment incl. clinical progression due to bone irradiationTimeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
- Duration of response (DOR) based on central assessmentTimeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
- Maximum percent reduction in target lesion size based on central assessmentTimeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
- AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state)Timeframe: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
Additional Information
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