Advanced/Metastatic Medullary Thyroid Cancer (MTC), Symptomatic, Aggressive, Sporadic, Unresectable, Locally
Conditions
Keywords
RET Mutation, DIagnostics, Medullary Thyroid Cancer, MTC
Brief 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.
Interventions
Vandetanib commercial tablets
Sponsors
Worldwide Clinical Trials
Genzyme, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Safety by assessment of laboratory data | From enrollment until study completion, assessed up to 38 months | Assessment of Laboratory data |
| Assessment of Objective Response Rate | From enrollment until study completion, assessed up to 38 months | Assessment of Objective Response Rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\] |
| Assessment of Disease control rate | From enrollment until study completion, assessed up to 38 months | Assessment of Disease control rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\] |
| Assessment of Duration of Response | From enrollment until study completion, assessed up to 38 months | Assessment of Duration of Response (using RECIST 1.1) |
| Assessment of Progression Free Survival | From enrollment until study completion, assessed up to 38 months | Assessment of Progression Free Survival (using RECIST 1.1) |
| Evaluation of Safety by assessment of QTc prolongations | From enrollment until study completion, assessed up to 38 months | Assessment of QTc prolongations |
| Evaluation of Safety by assessment of Adverse Events | From enrollment until study completion, assessed up to 38 months | Assessment of Adverse Events |
| Evaluation of Safety by assessment of vital signs | From enrollment until study completion, assessed up to 38 months | Assessment of Vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Characteristics | From enrollment until study completion, assessed up to 38 months | Patient demographics and medical history / Disease characteristics / Death / Treatment information |
Countries
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Spain, United Kingdom
Outcome results
None listed