Status:
COMPLETED
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Lead Sponsor:
Bayer
Collaborating Sponsors:
Amgen
Conditions:
Thyroid Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine
Detailed Description
Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT00984282
Start Date
October 15 2009
End Date
August 30 2017
Last Update
September 13 2018
Active Locations (81)
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1
Los Angeles, California, United States, 90048
2
Stanford, California, United States, 94305-5820
3
New Haven, Connecticut, United States, 06520
4
Atlanta, Georgia, United States, 30322