This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.
This is a multinational, multicenter, non-interventional (observational) and prospective study. European countries where vandetanib is on the market will participate in the study. This study is being conducted to fulfil the specific obligation post-authorisation measure for the conditional marketing authorisation. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC. The clinical benefit of vandetanib (CAPRELSA™) 300 mg has previously been established in a clinical trial (Study 58) on the basis of a clinically and statistically significant advantage in progression free survival (PFS) which was supported by a high response rate and substantial duration of response.
Study Type
OBSERVATIONAL
Enrollment
31
Vandetanib commercial tablets
investigational Site Belgium
Belgium, Belgium
investigational Site France
France, France
investigational Site Germany
Germany, Germany
investigational Site Italy
Italy, Italy
Assessment of Objective Response Rate
Assessment of Objective Response Rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\]
Time frame: From enrollment until study completion, assessed up to 38 months
Assessment of Disease control rate
Assessment of Disease control rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\]
Time frame: From enrollment until study completion, assessed up to 38 months
Assessment of Duration of Response
Assessment of Duration of Response (using RECIST 1.1)
Time frame: From enrollment until study completion, assessed up to 38 months
Assessment of Progression Free Survival
Assessment of Progression Free Survival (using RECIST 1.1)
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of QTc prolongations
Assessment of QTc prolongations
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of Adverse Events
Assessment of Adverse Events
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of vital signs
Assessment of Vital signs
Time frame: From enrollment until study completion, assessed up to 38 months
Evaluation of Safety by assessment of laboratory data
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investigational Site Luxembourg
Luxembourg, Luxembourg
investigational Site Netherlands
Netherlands, Netherlands
investigational Site Spain
Spain, Spain
investigational Site United Kingdom
United Kingdom, United Kingdom
Assessment of Laboratory data
Time frame: From enrollment until study completion, assessed up to 38 months
Patient Characteristics
Patient demographics and medical history / Disease characteristics / Death / Treatment information
Time frame: From enrollment until study completion, assessed up to 38 months