AstraZeneca is pleased to announce two new clinical trials for patients with differentiated thyroid cancer.
The first, ASTRA (Adjuvant Selumetinib for differentiated Thyroid cancer, Remission after RAI), is a randomized, double-blind, placebo-controlled study (NCT01843062) designed to compare the efficacy of a short course of selumetinib, a MEK inhibitor, plus adjuvant RAI versus placebo plus RAI in patients with newly diagnosed DTC at high risk of primary treatment failure. ASTRA is the first randomized clinical study to assess whether the efficacy of RAI can be improved by the addition of an agent capable of enhancing RAI uptake in patients with DTC. The study offers a unique trial design by investigating early disease intervention in an adjuvant setting with the aim of improving the complete remission rate and clinical outcome in a high-risk population. AstraZeneca and the study authors worked with regulatory agencies to gain critical input on the novel ASTRA study design, including its patient population criteria and study endpoints.
ASTRA can be found at ClinicalTrials.gov at: http://clinicaltrials.gov/ct2/show/NCT01843062?term=NCT01843062&rank=1
The second, VERIFY (Vandetanib Efficacy in RAI-Ineligible Refractory Thyroid cancer) is a Phase III double-blind, placebo-controlled study (NCT01876784) to assess the efficacy and safety of vandetanib in patients with DTC that is either locally advanced or metastatic and refractory or unsuitable for RAI. Patients will be randomized 1:1 to daily vandetanib 300 mg or matching placebo. The primary endpoint, PFS, will be defined as the time from randomization to the first documentation of objective disease progression or death from any cause. Overall survival (OS), a secondary endpoint, will be defined as the time between the date of randomization and the date of patient death due to any cause.
VERIFY can be found at ClinicalTrials.gov at: http://clinicaltrials.gov/ct2/show/NCT01876784?term=NCT01876784&rank=1