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

Trial ID or NCT#

NCT00984282

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
Harlan Pinto
Harlan Pinto
Medical oncologist, Head and neck specialist
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Contact us to find out if this trial is right for you.

Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov