NCT00127829已完成1 期
A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 66
- 试验地点
- 1
研究概览
简要总结
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 solid tumor refractory to conventional treatment or whom no standard of treatment exists
- •Life expectancy of > 12 weeks
- •World Health Organization (WHO) performance status of < 2
排除标准
- •Known severe hypersensitivity to gefitinib or any of the excipients of this product
- •Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)
- •Incomplete healing from previous oncologic or other major surgery
研究组 & 干预措施
1
Experimental
Gefitinib (IRESSA®)
干预措施: Gefitinib (Drug)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.CancerNCT01248858GlaxoSmithKline69
已完成
1 期
Study of TAK-901 in Adults With Advanced Solid Tumors or LymphomaAdvanced Solid TumorsLymphomaNCT00935844Millennium Pharmaceuticals, Inc.20
已完成
1 期
Dose Escalation Study of Continuous Once-daily Oral Treatment With BIBW 2992 in Patients With Advanced Solid TumorsNeoplasmsNCT02171728Boehringer Ingelheim30
已完成
1 期
Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom MacroglobulinemiaRelapsed Multiple MyelomaRefractory Multiple MyelomaWaldenstrom MacroglobulinemiaNCT01118689Millennium Pharmaceuticals, Inc.39
已完成
1 期
A Phase I Study of CS1002 in Subjects With Advanced Solid TumorsAdvanced Solid TumorNCT04338724CStone Pharmaceuticals6