Observational Study to evaluate Vandetanib in RET -/+ Patients with Metastatic Medullary Thyroid Cancer - Caprelsa104

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
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