EUCTR2007-006120-36-NL进行中（未招募）不适用
Phase I/II Study of Combined Treatment with AT-101, Cisplatin and Radiotherapy in Patients with Locally Advanced Head and Neck Cancer
未提供0 个研究点目标入组 50 人开始时间: 2008年12月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically proven squamous cell carcinoma of the head and neck
- •Oral cavity, oropharyngeal, or hypopharyngeal carcinoma
- •Inoperable TNM stage III/IV, M0
- •Patient must have measurable disease
- •age > 18 years
- •performance status WHO 0-2 (see Appendix B)
- •No prior radiation therapy to head and neck region
- •No prior cisplatin-based chemotherapy
- •Adequate laboratory results:
- •oWBC > 4.0
- •oplatelets > 100,000
- •ocalculated or 24 hour creatinine clearance > 50 ml/min
- •oASAT/ALAT < 2.5 times upper limit of normal range
- •oBilirubin < 1.5 x upper limit of institution's normal range
- •No uncontrolled arrhythmia
- •No breast feeding or pregnancy
- •Willingness to use contraception by a method that is deemed effective by the Investigator throughout the treatment period and for at least 30 days following the last dose of therapy
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Entry criteria for translational research:
- •oWilling and able to undergo blood sampling, harvesting of buccal smears and tumor biopsy (mandatory)
- •oWilling and able to undergo skin biopsy and nuclear scanning (optional)
- •Willing and able to undergo blood sampling for pharmacokinetics
- •Signed written informed consent before entry into study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
- •Patients with Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification (see Appendix C) are excluded.
- •Patients with known active symptomatic fungal, bacterial and/or viral infection including active HIV are excluded. Note: protocol does not require screening for viruses; however, patients with known active infections are excluded.
研究者
相似试验
尚未招募
不适用
Phase I/II study of combined treatment with AT-101, cisplatin and radiotherapy in patients with locally advanced head and neck cancerhead and neck squamous cell carcinomahead and neck cancer10027655NL-OMON33661Antoni van Leeuwenhoek Ziekenhuis50
已完成
2 期
Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT00286780Ascenta Therapeutics19
尚未招募
2 期
Study of the effect of telmisartan on fibrosis in fatty liver diseaseon-alcoholic steatohepatitis (NASH)Non-alcoholic steatohepatitis (NASH)Inflammatory and Immune System - LiverACTRN12606000411549Professor Peter Angus40
招募中
不适用
A phase I study of conbination therapy with intratumorak administration of dendritic cells and radiation for far advanced esophageal cancerEsophageal cancerJPRN-UMIN000012218Chiba University6
进行中（未招募）
1 期
Study to observe efficacy and safety of AM-101 in patients with tinnitusacute peripheral tinnitus following traumatic cochlear injury or otitis mediaMedDRA version: 20.0Level: PTClassification code 10043882Term: TinnitusSystem Organ Class: 10013993 - Ear and labyrinth disordersEUCTR2012-004099-20-PLAuris Medical AG750