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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00410761 |
The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
Condition | Intervention | Phase |
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Thyroid Cancer |
Drug: ZD6474 (Vandetanib) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An International, Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMA™ ) Versus Placebo in Subjects With Unresectable, Locally Advanced or Metastatic Medullary Thyroid Cancer. |
Enrollment: | 328 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Placebo vandetanib
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2: Experimental
Vandetanib
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Drug: ZD6474 (Vandetanib)
once daily oral tablet
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Peter Langmuir, MD | AstraZeneca |
Principal Investigator: | Samuel Wells, MD | Duke University |
Study ID Numbers: | D4200C00058 |
Study First Received: | December 6, 2006 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00410761 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; Italy: The Italian Medicines Agency; Romania: National Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Federal Institute for Drugs and Medical Devices; Mexico: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Sweden: Medical Products Agency; Hungary: National Institute of Pharmacy; France: Afssaps - French Health Products Safety Agency; Austria: Agency for Health and Food Safety; Denmark: Danish Medicines Agency; Poland: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines; Korea: Food and Drug Administration; China: State Food and Drug Administration; India: Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health |
ZD6474 MTC Hereditary Medullary Thyroid Cancer Sporadic Medullary Thyroid Cancer Medullary Thyroid Cancer |
Thyroid Neoplasms Head and Neck Neoplasms Thyroid Cancer, Medullary Endocrine System Diseases |
Endocrinopathy Thyroid Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Thyroid Neoplasms Head and Neck Neoplasms |
Endocrine System Diseases Thyroid Diseases Endocrine Gland Neoplasms |