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CAPRELSA 104

Vandetanib in RET Mutation Negative and Positive Patients With Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer

Type d'étude Promoteur Etat actuel de l'étude
Phase IV AstraZeneca En cours de recrutement

 

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

Code de l’étude

Caprelsa104

Promoteur

AstraZeneca

Tumeur éligible

Symptomatic, Aggressive, Sporadic, Unresectable, Locally
Advanced/Metastatic Medullary Thyroid Cancer

Type d’étude

Interventionnelle, Vandetanib 300 mg

Phase

Observationnelle

Contact

Esther Pascual, PhD   Mail Pascual

Investigateur(s)

Martin Schlumberger

Centres

Europe dont France : Bordeaux, Lyon, Villejuif, Angers

Objectifs

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.
   - Assessment of Objective Response Rate, Disease control rate, Duration of Response, Progression Free Survival
   - Evaluation of Safety

Critères d’inclusion

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 bythe 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. The starting dose could be reduced to 200 mg in patients with moderate renal impairment

Critères d’exclusion

- Current or planned inclusion/participation in a clinical trial
- Patients already receiving vandetanib or who have received vandetanib for their MTC before the study first visit
- 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. (e) Serum bilirubin greater than 1.5 x the upper limit of reference range (f) Potassium, magnesium or calcium outside the normal laboratory range