Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer
Conditions
Symptomatic, Aggressive, Sporadic, Unresectable, Locally - Advanced/Metastatic Medullary Thyroid Cancer (MTC)
Conditions: official terms
Aggression - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
RET Mutation, DIagnostics, Medullary Thyroid Cancer, MTC
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Vandetanib 300 mg
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Signed informed consent 2. Male or female aged 18 years or above 3. Histological diagnosis of MTC 4. Patients with symptomatic and aggressive sporadic MTC, who have unresectable, locally advanced/metastatic disease. (The factors considered by the investigator to determine a patient's disease to be symptomatic and aggressive will be recorded in the CRF). 5. Measurable disease:

- assessment confirmed within the 12 weeks previous to start of treatment, and

- defined according to RECIST 1.1: at least one lesion, not irradiated, that can be accurately measured as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated measurements. Measurable lesions with calcifications should not be assessed as target lesions unless no other measurable lesion is available. 6. Known definite RET mutation status (definition according to section 3.2). The status should be:

- for patients prescribed with vandetanib: positive or negative

- for patients not prescribed with vandetanib: negative RET mutation status must be determined from a tumour sample obtained within 18 months prior to enrollment. It is strongly recommended that a tissue sample obtained within 6 months prior to enrolment is used. 7. For patients newly prescribed vandetanib 300 mg, the prescription should be issued according to marketing authorisation and following the vandetanib Summary of Product Characteristics (SmPC) (Appendix B). The starting dose could be reduced to 200 mg in patients with moderate renal impairment

- Exclusion criteria

1. Current or planned inclusion/participation in a clinical trial

2. Patients already receiving vandetanib or who have received vandetanib for their MTC before the study first visit

3. Contraindications according to the vandetanib SmPC (not applicable for patients who do not receive vandetanib): (a) Patients with a QT interval corrected for heart rate (QTc) interval over 480 msec: (i) Congenital long QT syndrome (ii) Concomitant use of vandetanib with the following medicinal products known to also prolong the QT interval and / or induce Torsades de pointes: Arsenic, cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, Class I A and III antiarrhythmics (b) Currently pregnant or breast feeding (c) Hypersensitivity to the active substance or to any of the excipients (d) Severe renal impairment: creatinine clearance < 30 ml/minute calculated by Cockcroft-Gault formula. (See Appendix D). (e) Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR) (f) Potassium, magnesium or calcium outside the normal laboratory range
Locations
Research Site
Brussels, Belgium
Status: Active, not recruiting
Research Site
Bordeaux, France
Status: Active, not recruiting
Research Site
Lyon, France
Status: Terminated
Research Site
Paris, France
Status: Active, not recruiting
Research Site
Villejuif, France
Status: Recruiting
Research Site
Augsburg, Germany
Status: Recruiting
Research Site
Essen, Germany
Status: Active, not recruiting
Research Site
Heidelberg, Germany
Status: Active, not recruiting
Research Site
Munchen, Germany
Status: Active, not recruiting
Research Site
Catania, Italy
Status: Active, not recruiting
Research Site
MIlano, Italy
Status: Recruiting
Research Site
Milano, Italy
Status: Active, not recruiting
Research Site
Naples, Italy
Status: Active, not recruiting
Research Site
Padova, Italy
Status: Active, not recruiting
Research Site
Pisa, Italy
Status: Recruiting
Research Site
Siena, Italy
Status: Recruiting
Research Site
Luxembourg, Luxembourg
Status: Active, not recruiting
Research Site
Groningen, Netherlands
Status: Active, not recruiting
Research Site
Leiden, Netherlands
Status: Recruiting
Research Site
Barcelona, Spain
Status: Recruiting
Research Site
Madrid, Spain
Status: Active, not recruiting
Research Site
Madrit, Spain
Status: Not yet recruiting
Research Site
Oviedo, Spain
Status: Active, not recruiting
Research Site
Sevilla, Spain
Status: Terminated
Research Site
Glasgow, United Kingdom
Status: Terminated
Research Site
London, United Kingdom
Status: Recruiting
Research Site
London, United Kingdom
Status: Terminated
Research Site
London, United Kingdom
Status: Active, not recruiting
Research Site
Manchester, United Kingdom
Status: Active, not recruiting
Research Site
Sheffield, United Kingdom
Status: Active, not recruiting
Research Site
Sutton, United Kingdom
Status: Recruiting
Start Date
February 2014
Completion Date
October 2018
Sponsors
AstraZeneca
Source
AstraZeneca
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page