NCT02608411终止2 期
TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES). Phase II Clinical Trial, Single Arm, Two Stage
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study aims to assess the role of MET inhibitors as maintenance treatment in adult patients with extensive stage small cell lung cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed extensive-stage SCLC
- •Disease control after the first line platinum/etoposide treatment
- •ECOG performance status of 0 or 1
- •Measurable disease according to RECIST Version 1.1 criteria
- •Adequate bone marrow, liver, and renal function.
- •Formalin Fixed Paraffin Embedded (FFPE) or frozen tumor tissue material must be available.
- •Resolution of any toxic effects of prior therapy according to NCI CTCAE, v 4.0
- •Full recovery from significant complications of the surgery
- •If childbearing age, use of double-barrier contraceptive measures, oral or abstaining from sexual intercourse during the study and up to 90 days after the last dose of chemotherapy
- •Negative pregnancy test within 72 hours prior to the initiation of study treatment, if of childbearing potential
- •Signed informed consent prior to beginning protocol specific procedures
- •Patients must be available for treatment and follow-up
排除标准
- •Previous therapies with Tivantinib or other known c-MET inhibitor
- •Radiotherapy for target lesions and major surgical procedure within 4 weeks, prior to the inclusion in the study
- •Palliative radiotherapy within 2 weeks prior to the inclusion in the study
- •History of malignancy in the past five years, excluding basal cell the cervix, prostate cancer with a value of prostate-specific antigen <0.2 ng / mL
- •History of cardiac disease
- •Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infections
- •Pregnant or lactating women or childbearing/reproductive potential not using adequate contraception
- •Need for breastfeeding during or within 12 weeks of completion of the study
- •Gastrointestinal disorders that may interfere with the absorption of Tivantinib
- •Inability or unwillingness to swallow the complete doses of Tivantinib
- •Any known contraindication to treatment and other significant comorbid conditions which could jeopardize participation in the study
研究组 & 干预措施
ARQ-197
Experimental
ARQ-197 360 mg twice/day by mouth (PO), with meals, continuously as maintenance treatment until disease progression or unacceptable toxicity.
干预措施: ARQ197 (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Approximately 48 months
PFS will be assessed From the date of enrollment to the date of first documented disease progression or to the date of death from any cause or to the date of a new anti-cancer therapy, whichever occurs first. Patients without a PFS event at the time of analysis will be censored at the date of last assessment.
次要结局
- Overall survival (OS)(Approximately 48 months)
- Disease control rate (DCR)(Approximately 48 months)
- Occurrence of all grade toxicity events assessed by CTCAE v4.0(Toxicity will be recorded during the treatment, until 30 days after the last dose of study medication, and graded according to the NCI- Common Terminology Criteria for Adverse Events (CTCAE) v.4.)
- Quality of Life(Approximately 48 months)
研究者
研究点 (1)
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