Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Thyroid Neoplasms

In brief

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Key facts

Study ID

NCT00984282

Run by

Bayer

People needed

417

Starts

2009-10-15

Expected to finish

2017-08-30

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Stanford, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Vienna, Austria
• Study site — Bruxelles - Brussel, Belgium
• Study site — Sofia, Bulgaria
• Study site — Guangzhou, Guangdong, China
• Study site — Beijing, China
• Study site — Beijing, China
• Study site — Chengdu, China
• Study site — Hangzhou, China
• Study site — Shanghai, China
• Study site — Shanghai, China
• Study site — Tianjin, China
• Study site — Odense C, Denmark
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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