A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 83
- 主要终点
- Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
研究概览
简要总结
This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.
详细描述
Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
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
- •Main inclusion criteria:
- •Diagnosis of small cell lung cancer.
- •Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.
- •[Additional eligibility criteria apply.]
排除标准
- •Prior radiotherapy that included > 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
- •Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
- •Significant heart disease.
- •Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
- •Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).
- •[Additional exclusion criteria apply.]
结局指标
主要结局
Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)
次要结局
未报告次要终点