EUCTR2005-000597-53-DE进行中（未招募）不适用
Phase II study to investigate the efficacy and safety of ZK 219477 as first-line therapy in chemotherapy naive patients with extensive disease (ED) stage small cell lung cancer (SCLC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
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
- •1. Males or females aged >= 18 years
- •2. Histologically or cytologically proven SCLC
- •3. Stage of extensive disease defined by the presence of distant metastases
- •4. At least 1 unidimensionally measurable lesion (suitable for modRECIST
- •evaluation)
- •5. WHO performance status 0 to 1
- •6. No previous SCLC-related chemotherapy
- •7. No previous SCLC-related surgery
- •8. No previous radiotherapy (excepting for brain metastases)
- •9. Adequate function of major organs and systems
- •Nervous system:
- •- No Grade 2 or greater peripheral neuropathy
- •Hematopoietic:
- •- Hemoglobin: >= 10 g/dL
- •- WBC: >= 3,000/mm3
- •- Absolute neutrophil count: >= 1,500/mm3
- •- Platelet count: >= 100,000/mm3
- •- Total bilirubin: normal
- •- AST/ALT: <= 2.5 times the upper limit of normal
- •Renal: -Creatinine: <= 2 mg/dL
- •Cardiovascular:
- •- No symptomatic congestive heart failure
- •- No unstable angina pectoris
- •- No arrhythmia needing continuous treatment
- •No other uncontrolled concurrent illness
- •10. Negative pregnancy test at enrollment (females of childbearing potential only)
- •11. Agreement to use highly effective contraception methods (intra-uterine
- •contraceptive device IUCD, condoms, oral contraceptives, or other adequate
- •barrier contraception) in females of child-bearing potential
- •12. Written informed consent
- •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
- •1. Superior vena cava syndrom or obstruction of any vital structure
- •2. Untreated malignant hypercalcemia
- •3. Pleural effusion as the only manifestation of disease
- •4. Extensive disease amenable to radiation therapy
- •5. Symptomatic brain metastases requiring whole-brain irradiation
- •6. Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma
- •in situ of the cervix
- •7. Pregnant or breast-feeding women
- •8. Any condition that in the opinion of the investigator could hamper the compliance
- •with the study protocol
研究者
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