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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00537095 |
This is a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether ZACTIMA confers an improvement in PFS as compared to placebo in subject with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial should be of a sufficient size so that if ZACTIMA is truly active there is a high probability that it will demonstrate an effect sufficiently promising to warrant a follow-up assessment.
Subjects will be seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all subjects (both active and placebo) will be unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label ZACTIMA 300 mg treatment. All subjects will be followed to collect survival data until
Condition | Intervention | Phase |
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Thyroid Neoplasms |
Drug: 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: | A Randomized, Double Blind, Placebo-Controlled Phase II, Multi-Centre Study to Assess the Efficacy and Safety of Zactima™ in Patients With Locally Advanced or Metastatic Papillary or Follicular Thyroid Carcinoma Failing or Unsuitable for Radioiodine Therapy |
Estimated Enrollment: | 135 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 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
ZACTIMA™ (ZD6474)
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Drug: Vandetanib
300 mg oral once daily oral dose
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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:
Subjects with atrial fibrillation controlled by medication are permitted.
Belgium | |
Research Site | |
Bruxelles, Belgium | |
Denmark | |
Research Site | |
Odense, Denmark | |
France | |
Research Site | |
Angers Cedex, France | |
Research Site | |
Bordeaux Cedex, France | |
Research Site | |
Marseille Cedex, France | |
Research Site | |
Lille Cedex, France | |
Research Site | |
Lyon Cedex, France | |
Research Site | |
Caen Cedex, France | |
Research Site | |
Paris, France | |
Research Site | |
Villejuif, France | |
Norway | |
Research Site | |
Oslo, Norway | |
Portugal | |
Research Site | |
Coimbra, Portugal | |
Research Site | |
Porto, Portugal | |
Spain | |
Research Site | |
Madrid, Spain | |
Sweden | |
Research Site | |
Lund, Sweden | |
Research Site | |
Stockholm, Sweden | |
Switzerland | |
Research Site | |
Bern, Switzerland |
Study Chair: | Brigitte Loop | AstraZeneca |
Principal Investigator: | Martin Schlumberger, MD | AstraZeneca |
Principal Investigator: | Eric Gauthier, MD | AstraZeneca |
Study Director: | Peter Langmuir, MD | AstraZeneca |
Study ID Numbers: | D4200C00079 |
Study First Received: | September 27, 2007 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00537095 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Sweden: Medical Products Agency; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic |
follicular papillary |
Adenocarcinoma, Follicular Thyroid Neoplasms Thyroid Cancer, Follicular Head and Neck Neoplasms Endocrine System Diseases |
Endocrinopathy Thyroid Diseases Endocrine Gland Neoplasms Carcinoma |
Neoplasms Neoplasms by Site Thyroid Neoplasms Head and Neck Neoplasms |
Endocrine System Diseases Thyroid Diseases Endocrine Gland Neoplasms |