Trials / Completed
CompletedNCT01945762
Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer
European, Observational, Prospective Study to Evaluate the Benefit/Risk of Vandetanib in RET Mutation Negative and Positive Patients With Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 31 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Symptomatic, Aggressive, Sporadic, Unresectable, Locally
- Advanced/Metastatic Medullary Thyroid Cancer (MTC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vandetanib 300 mg | Vandetanib commercial tablets |
Timeline
- Start date
- 2014-02-17
- Primary completion
- 2020-06-18
- Completion
- 2020-06-18
- First posted
- 2013-09-19
- Last updated
- 2024-12-18
Locations
8 sites across 8 countries: Belgium, France, Germany, Italy, Luxembourg, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01945762. Inclusion in this directory is not an endorsement.