©2022 Stanford Medicine
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Not Recruiting
Trial ID: NCT00984282
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
Stanford Investigator(s)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Heather Wakelee
Professor of Medicine (Oncology)
Harlan Pinto
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Eligibility
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
Intervention(s):
drug: Placebo
drug: Sorafenib (Nexavar, BAY43-9006)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061