Advanced/Metastatic Medullary Thyroid Cancer (MTC) Clinical Trial
— Caprelsa104Official title:
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
| Verified date | October 2020 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | June 18, 2020 |
| Est. primary completion date | June 18, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | investigational Site Belgium | Belgium | |
| France | investigational Site France | France | |
| Germany | investigational Site Germany | Germany | |
| Italy | investigational Site Italy | Italy | |
| Luxembourg | investigational Site Luxembourg | Luxembourg | |
| Netherlands | investigational Site Netherlands | Netherlands | |
| Spain | investigational Site Spain | Spain | |
| United Kingdom | investigational Site United Kingdom | United Kingdom |
| Lead Sponsor | Collaborator |
|---|---|
| Genzyme, a Sanofi Company | Worldwide Clinical Trials |
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of Objective Response Rate | Assessment of Objective Response Rate [using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1] | From enrollment until study completion, assessed up to 38 months | |
| Primary | Assessment of Disease control rate | Assessment of Disease control rate [using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1] | From enrollment until study completion, assessed up to 38 months | |
| Primary | Assessment of Duration of Response | Assessment of Duration of Response (using RECIST 1.1) | From enrollment until study completion, assessed up to 38 months | |
| Primary | Assessment of Progression Free Survival | Assessment of Progression Free Survival (using RECIST 1.1) | From enrollment until study completion, assessed up to 38 months | |
| Primary | Evaluation of Safety by assessment of QTc prolongations | Assessment of QTc prolongations | From enrollment until study completion, assessed up to 38 months | |
| Primary | Evaluation of Safety by assessment of Adverse Events | Assessment of Adverse Events | From enrollment until study completion, assessed up to 38 months | |
| Primary | Evaluation of Safety by assessment of vital signs | Assessment of Vital signs | From enrollment until study completion, assessed up to 38 months | |
| Primary | Evaluation of Safety by assessment of laboratory data | Assessment of Laboratory data | From enrollment until study completion, assessed up to 38 months | |
| Secondary | Patient Characteristics | Patient demographics and medical history / Disease characteristics / Death / Treatment information | From enrollment until study completion, assessed up to 38 months |