NCT01736878撤回2 期
Randomized Double-blind Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Sorafenib Treatment in Patients With Advanced (Recurrent, Persistent and/or Metastasizing) Medullary Thyroid Carcinoma
Eanm Research Ltd1 个研究点 分布在 1 个国家开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.
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, Investigator, Outcomes Assessor)
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
- •Inpatient or outpatient ≥ 18 years of age
- •Histologically confirmed medullary thyroid carcinoma
- •Recurrent or persistent local disease and/or distant metastases
- •No more than one prior line of systemic therapy
- •Best available supportive care to control (endocrine) symptoms
- •At least one defined lesion in CT or MRI evaluable for Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or at least one defined lesion in CT or MRI not evaluable by RECIST in combination with elevated tumour markers
- •Progression within previous 12 months
- •Hb > 8g/dl, white blood cells (WBC) >3.000 cells/mm³ (ANC > 1.500 cells/mm³), platelets > 100.000 cells/mm³, bilirubin < 2mg/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)
- •Performance status: WHO ≤ 2; Karnofsky index ≥ 50%
- •Sufficient renal function (creatinin <1.5 mg/dl and creatinin clearance > 30ml/min)
- •International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
- •No acute infections
- •Staging studies (MRT or CT and Calcitonin or CEA) completed within four weeks of protocol randomisation
- •Women of childbearing potential with negative serum pregnancy test
- •Women and men of childbearing potential using adequate contraception
- •Signed and dated written informed consent
排除标准
- •Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE version 4) Grade 2 (excluding cases of alopecia)
- •Patients with history of allergic or hypersensitivity reaction to study drug or placebo or their excipients
- •Current participation in another investigational trial
- •Patients with significant cardiovascular disease
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin
- •Congenital long corrected QT interval (QTc) syndrome, history of drug induced QTc prolongation, or QTc interval unmeasurable or more than 450 ms
- •Abnormal serum electrolytes such as potassium, magnesium and calcium
- •Uncontrolled hypertension, despite optimal management
- •Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization
- •Non-healing wound, ulcer, or bone fracture
- •Evidence or history of bleeding diathesis or coagulopathy disorder
- •Hemorrhage/bleeding event ≥ Grade 3
- •Thrombotic or embolic events including transient ischemic attacks within the past 6 months
- •Subjects with symptomatic brain metastases or Subjects with brain metastases under corticosteroid treatment
- •Pregnant or breast-feeding patients
- •Patients with uncontrolled infections
- •Known HIV infection or infection with hepatitis B or C
- •Immunosuppression
- •Subjects with seizure disorder requiring medication • Subjects undergoing renal dialysis
- •Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- •Any malabsorption condition
研究组 & 干预措施
Sorafenib tablets
Experimental
Oral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity
干预措施: Sorafenib (Drug)
Placebo tablets
Placebo Comparator
Oral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: from the date of randomisation until the date of radiological or biochemical progression or death. An average of 9 months is assumed.
The proportion of patients with PFS in the Sorafenib group and the Placebo group will be compared by log rank test and Kaplan-Meier plot.
次要结局
- Time to Progression (TPP)(from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed.)
研究者
研究点 (1)
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