NCT01496313已完成4 期
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 81
- 试验地点
- 5
- 主要终点
- Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
研究概览
简要总结
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
详细描述
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
- •Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
- •World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-
- •Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
- •Lesions must be amenable to accurate and repeat measurement.
排除标准
- •Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
- •Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
- •Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
- •Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
- •For women only - currently pregnant or breast feeding.
研究组 & 干预措施
300mg vandetanib
Active Comparator
干预措施: 300mg vandetanib (Drug)
150mg vandetanib
Active Comparator
干预措施: 150mg vandetanib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
时间窗: Randomisation to week 60 (maximum)
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
次要结局
- Time to Objective Response (RECIST 1.1) by Treatment Arm(Randomization to Week 60 (maximum))
- Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm(Randomization to Week 60 (maximum))
- Duration of Objective Response (RECIST 1.1) by Treatment Arm(Randomization to Week 60 (maximum))
- Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.(Week 3 to week 60 (maximum))
- Best Objective Response(Randomisation to week 60 (maximum))
研究者
研究点 (5)
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