NCT02134990Unknown2 期
A Phase IIa, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
Oshadi Drug Administration1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年6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
- 20
- 试验地点
- 1
- 主要终点
- overall survival time
研究概览
简要总结
The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated.
Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.
CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3 Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be considered or subsequent therapy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic NSCLC (IIIB-IV)
- •Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
- •Man or woman 21 years and above
- •Adequate performance status (ECOG 0, and 1)
- •Patient must have adequate organ function
- •Written informed consent
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
排除标准
- •Any treatment with investigational agent within 10 days prior to registration for protocol therapy.
- •Cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months prior to registration for protocol therapy.
- •Evidence of pulmonary embolism within 3 months prior to registration for protocol therapy.
- •Any history of hematologic malignancies.
- •Patient with known positive HIV serology at screening.
- •Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- •Uncontrolled hypertension (>160/100 mm Hg despite optimal medical therapy).
- •Evidence of ongoing cardiac dysrhythmias of NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 grade
- •Patients in whom radiation or surgery is indicated
- •Significant swallowing disorders.
- •Small bowel surgery.
- •Suspicion of absorption disruption as a result of abdominal radiation
- •Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
- •Evidence of concurrent (< 5 years) second malignancy
- •Mental disorders.
- •Inability to give written informed consent.
研究组 & 干预措施
Oshadi D and Oshadi R with Docetaxel
Experimental
Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy
干预措施: Oshadi D and Oshadi R (Drug)
Oshadi D and Oshadi R with Docetaxel
Experimental
Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy
干预措施: Docetaxel (Drug)
结局指标
主要结局
overall survival time
时间窗: 12 months
overall survival of the patient
次要结局
- Patient report outcome(12 months)
- Adverse events and serious adverse events occurence(One month following treatment initiation)
研究者
研究点 (1)
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