Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer (Caprelsa104)
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
Sponsor: Genzyme, a Sanofi Company
A observational or N/A phase clinical study on Advanced/Metastatic Medullary Thyroid Cancer (MTC) and Symptomatic, Aggressive, Sporadic, Unresectable, Locally, this trial is completed. The trial is conducted by Genzyme, a Sanofi Company and has accumulated 11 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
11 versions recorded-
Jan 2025 — Present [monthly]
Completed
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Sep 2024 — Jan 2025 [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Jan 2021 — Jul 2024 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
Status: Unknown Status → Completed
▶ Show 6 earlier versions
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Aug 2020 — Nov 2020 [monthly]
Unknown Status
Status: Recruiting → Unknown Status
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Aug 2018 — Aug 2020 [monthly]
Recruiting
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Jun 2018 — Aug 2018 [monthly]
Recruiting
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Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: NA → None
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Mar 2017 — Apr 2018 [monthly]
Recruiting NA
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Jan 2017 — Mar 2017 [monthly]
Recruiting NA
First recorded
Feb 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Genzyme, a Sanofi Company
- Worldwide Clinical Trials
For direct contact, visit the study record on ClinicalTrials.gov .