NCT02007317已完成2 期
A Single Center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R in Patients With Basal Cell Carcinoma (BCC) Prior to Tumor Excision- a Phase II Study
Oshadi Drug Administration1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年11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
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events occurence
研究概览
简要总结
This study is single-arm, none randomized, open label, two-dose-cohorts, single center clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned surgical excision of the lesion.
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
- •Age > 21 years old with tissue confirmed diagnosis of local BCC.
- •Patient is candidate for surgical excision of the BCC in few months.
- •BCC lesion ≥10mm in its longest diameter.
- •Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception during therapy and 3 months after the last dose of the study drugs.
- •Female patients of childbearing potential must have a negative pregnancy test at screening.
- •Patient must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
排除标准
- •Uncontrolled Intercurrent illness or any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
- •Other active cancer disease.
- •Serum creatinine > 1.5 mg/dL for males and >1.4 mg/dL for females.
- •Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- •Any acute cardiovascular event during the last 6 months prior to inclusion.
- •Symptomatic congestive heart failure with ejection fraction < 30%.
- •Patient has prothrombin time/International Normalization Ration (PT/INR) or partial thromboplastin time (PTT) test results > 1.3 UNL.
- •Hemoglobin ≤ 11 g/dL
- •Platelets < 150,000 per microliter
- •White blood cell count<3,000 x109/L and/or absolute neutrophils count <1.5 x 109/L
- •Significant swallowing disorders.
- •History of small bowel surgery.
- •Any history of pelvic or abdominal radiation.
- •Pre-existing mal-absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
- •Mental disorders.
- •Inability to give written informed consent.
研究组 & 干预措施
Oshadi D and Oshadi R
Experimental
Anti tumor agents
干预措施: Oshadi D & Oshadi R (Drug)
结局指标
主要结局
Adverse events and serious adverse events occurence
时间窗: treatment end (day 60 or 90)
次要结局
- The primary efficacy endpoint of this study is Overall Response Rate (ORR)(treatment end (day 60 or 90))
研究者
研究点 (1)
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