NCT02775370Unknown2 期
Phase II Study of Apatinib Mesylate Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
This is a non-randomized, phase II, open label study of Apatinib Mesylate in patients with Head and neck recurrent/metastatic adenoid cystic carcinoma (ACC). The primary purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate in patients with ACC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenoid cystic carcinoma
- •Recurrent/Metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past. Progression must be documented according to RECIST criteria.
- •Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
- •Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and was previously treated with chemotherapy
- •18 years or older
- •Karnofsky score over 60
- •Previous treatment with chemotherapy, targeted agents, loco-regional therapy (e.g. chemoembolization) are permitted providing that toxicity has resolved to < or = grade 1 at study entry and that last treatment was at least 4 weeks prior to baseline assessment.
- •Adequate organ function
- •A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- •A patient who signed the informed consent prior to the participation of the study and who understands that he or she has a right to withdrawal from participation in the study at any time without any disadvantages.
排除标准
- •A patient with no measurable disease
- •Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry)
- •A patient with previous active or passive immunotherapy
- •A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding
- •A pregnant or lactating patient
- •A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential)
- •A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study
- •A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of skin and cervical carcinoma in situ.
- •A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
- •A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial infarction within past 12 months.
- •Ongoing cardiac arrhythmia of grade > or = 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for female.
- •A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
- •A patient with organ transplantation requiring immunosuppressive therapy
研究组 & 干预措施
Apatinib group
Experimental
Apatinib Mesylate administered as a daily oral treatment
干预措施: Apatinib Mesylate (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 6 months
To determine 6 month PFS of Apatinib Mesylate when administered as monotherapy in patients with metastatic adenoid cystic carcinoma
次要结局
- Overall survival rate(2 years)
- Response rate(8 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0(through study completion, an average of 2 years)
研究者
Guopei Zhu
M.D.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
研究点 (1)
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