NCT00112060撤回1 期
A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 26
研究概览
简要总结
This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.
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
- •Age ≥ 18 years
- •Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).
- •Asymptomatic or treated brain metastases (including steroids) if last therapy was received > 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.
- •ECOG performance status 0 -
- •Adequate organ function and bone marrow reserve.
- •Use of appropriate contraceptive method.
- •Signed patient informed consent.
排除标准
- •Investigational agents within 30 days prior to Day 1 of study.
- •Known symptomatic or uncontrolled brain metastases.
- •Uncontrolled intercurrent illness.
- •Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.
- •Patient has uncontrolled pleural effusions.
- •Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.
研究者
研究点 (26)
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