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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00654238 |
The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.
Condition | Intervention | Phase |
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Metastatic Differentiated Thyroid Cancer Metastatic Poorly Differentiated Thyroid Cancer Metastatic Anaplastic Thyroid Cancer Metastatic Medullary Thyroid Cancer |
Drug: sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer |
Estimated Enrollment: | 55 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
This is a single arm study.
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Drug: sorafenib
400mg PO BID daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Post-menopausal women must be amenorrheic for at least 12 months to be considered non-child-bearing potential. Male and female patients of reproductive potential must agree to use adequate contraception (i.e. hormonal or barrier method of birth control). throughout the study and for 3 months after the study.
Exclusion Criteria:
Contact: Maryann Redlinger, RN | 215-662-7452 | Maryann.Redlinger@uphs.upenn.edu |
Contact: Vicki Baldassarre | 215-662-7402 | Victoria.Baldassarre@uphs.upenn.edu |
United States, Pennsylvania | |
University of Pennsylvania - Abramson Comprehensive Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Maryann Redlinger, RN 215-662-7452 Maryann.Redlinger@uphs.upenn.edu | |
Contact: Vicki Baldassarre 215-662-7402 Victoria.Baldassarre@uphs.upenn.edu |
Principal Investigator: | Marcia S Brose, MD PhD | Unviersity of Pennsylvania - Abramson Comprehensive Cancer Center |
Responsible Party: | University of Pennsylvania ( Marcia S. Brose MD PhD/Principle Investigator ) |
Study ID Numbers: | 802861, UPCC 03305 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00654238 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Thyroid Cancer Anaplastic Medullary sorafenib |
Thyroid Neoplasms Head and Neck Neoplasms Thyroid Cancer, Medullary Endocrine System Diseases Thyroid Cancer, Anaplastic |
Endocrinopathy Protein Kinase Inhibitors Sorafenib Thyroid Diseases Endocrine Gland Neoplasms |
Molecular Mechanisms of Pharmacological Action Thyroid Neoplasms Antineoplastic Agents Endocrine System Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Sorafenib Thyroid Diseases Endocrine Gland Neoplasms |