EUCTR2006-000067-29-DE进行中（未招募）不适用
Phase I/II study to investigate the safety, tolerability, efficacy and pharmacokinetics of ZK 219477 in combination with cisplatin 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）
- 入组人数
- 52
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
- •Patients must meet the following criteria to enroll in this study:
- •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. Adequate function of major organs and systems
- •Hematopoietic:
- •- Hemoglobin >10 g/dL
- •- WBC:> 3.0 x 109/L
- •- Absolute neutrophil count: >1.5 x 109/L
- •- Platelet count: >100 x 109/L
- •- Total bilirubin: within normal range (< 1.5 times the upper limit of normal in
- •case of liver metastases)
- •- AST/ALT:< 2.5 times the upper limit of normal (< 5 times the upper limit of
- •normal in case of liver metastases)
- •- Creatinine: <1.5 times the upper limit of normal
- •- Creatinine clearance: > 60 ml/min
- •Cardiovascular:No symptomatic congestive heart failure
- •- No unstable angina pectoris
- •- No myocardial infarction < 6 months prior to randomization
- •- No arrhythmia needing continuous treatment
- •Nervous system:
- •- No Grade 2 or greater peripheral neuropathy
- •- No Grade 2 or greater hearing impairment
- •No other uncontrolled concurrent illness
- •No active infection
- •7. Survival expectation of at least three months
- •8. Negative pregnancy test at enrollment (females of childbearing potential only)
- •9. Agreement to use a highly effective method of birth control for adults of
- •reproductive potential
- •10. 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
- •Patients must not be enrolled if they meet any of the following criteria:
- •1. Prior chemotherapy for SCLC
- •2. Prior surgical resection for SCLC within 4 weeks prior to inclusion. Patient must
- •have recovered from all therapy related toxicities.
- •3. Prior radiotherapy for SCLC with the exception of radiation of brain metastases.
- •At least 3 weeks must have elapsed since radiotherapy and patient must have
- •recovered from all therapy related toxicities; the site of previous radiotherapy
- •should have evidence of progressive disease if it is the only site of disease.
- •4. Superior vena cava syndrome or obstruction of any vital structure
- •5. Untreated malignant hypercalcemia
- •6. Extensive disease amenable to radiation therapy
- •7. Symptomatic brain metastases requiring whole-brain irradiation (please note:
- •patients with brain metastases not requiring whole brain irradiation can be
- •8. History of another primary malignancy within the last 5 years with the exceptions
- •of non-melanoma skin cancer and carcinoma in situ of the cervix
- •9. Known allergy or hypersensitivity to platinum-containing drugs
- •10. Pregnant or breast-feeding women
- •11. Any condition that in the opinion of the investigator could hamper the compliance
- •with the study protocol
- •12. Use of any investigational drug within 4 weeks before start of study treatment
- •or inadequate recovery from any toxic effects of such therapy
研究者
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