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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Evaluation of Safety by assessment of QTc prolongations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male or female aged 18 years or above
- •Histological diagnosis of MTC
- •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).
- •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.
- •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.
- •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
- •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. (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
排除标准
- 未提供
研究组 & 干预措施
1. patient cohorts (40 patients/cohort)
RET positive patient cohorts
干预措施: Vandetanib 300 mg (Drug)
2. patient cohorts (40 patients/cohort)
RET negative patient cohorts
干预措施: Vandetanib 300 mg (Drug)
结局指标
主要结局
Evaluation of Safety by assessment of QTc prolongations
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of QTc prolongations
Assessment of Duration of Response
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of Duration of Response (using RECIST 1.1)
Assessment of Progression Free Survival
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of Progression Free Survival (using RECIST 1.1)
Assessment of Objective Response Rate
时间窗: 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
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of Disease control rate \[using Response Evaluation Criteria In Solid Tumours (RECIST) 1.1\]
Evaluation of Safety by assessment of vital signs
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of Vital signs
Evaluation of Safety by assessment of Adverse Events
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of Adverse Events
Evaluation of Safety by assessment of laboratory data
时间窗: From enrollment until study completion, assessed up to 38 months
Assessment of Laboratory data
次要结局
- Patient Characteristics(From enrollment until study completion, assessed up to 38 months)