An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And
Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or
Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Change from baseline, overall response rate (ORR) for vandetanib 150 and 300mg with responses determined by the Investigator
ORR=percentage of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Randomisation to week 60 (maximum)
No
James Vasselli, MD
Study Chair
AZ MSD
United States: Food and Drug Administration
D4200C00097
NCT01496313
June 2012
May 2015
Name | Location |
---|---|
Research Site | Abilene, Texas |