A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Medullary Thyroid Carcinoma(ALTER01031)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 19
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
- •ECOG PS:0-1,Life expectancy of more than 6 months
- •main organs function is normal
排除标准
- •Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
- •Subjects received radiotherapy external exposure within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study
- •Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]
- •CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin
- •Patients with factors that could affect oral medication (such as dysphagia etc.)
- •Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])
- •Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
研究组 & 干预措施
Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Subjects who received Anlotinib will not be eligible for the open-label phase.
干预措施: Anlotinib (Drug)
Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 months)
To compare the Progression-free Survival (PFS) of subjects with medullary thyroid carcinoma(MTC) with Anlotinib versus Placebo.
次要结局
- Overall Response Rate (ORR)(Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months))