A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA) 300 mg in Patients With Papillary or Poorly Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the
Efficacy and Safety of Vandetanib (CAPRELSA) 300 mg in Patients with Papillary or Poorly
Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are
Refractory or Unsuitable for Radioiodine (RAI) Therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Determination of the efficacy (as assessed by progression-free survival) of vandetanib when compared to placebo in the patient population
Once 155 progression events have occurred. RECIST measurements taken every 12 weeks from randomization. Time point(s) at which outcome measure is assessed.
Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow-up).
No
Martin Schlumberger, PROFESSOR, M.D.
Principal Investigator
Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, 94805 Villejuif, France
France: Agence Nationale de Sécurité du Médicament et des produits de santé
D4203C00011
NCT01876784
July 2013
May 2017
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