NCT00090675撤回3 期
A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- AstraZeneca
研究概览
简要总结
In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •Must sign Informed Consent
- •Females and males aged 18 years and over.
- •Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
- •Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.
- •No prior EGFR therapy
- •No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy
- •At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy
- •Must be completely healed from previous major oncologic surgery
- •Life expectancy of ≥ 8 weeks.
排除标准
- •Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
- •Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- •Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
- •Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
- •Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- •Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.
- •Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.
- •Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.
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