EUCTR2015-005069-21-ES进行中（未招募）1 期
A Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease Small Cell Lung Cancer
illy S.A.0 个研究点目标入组 116 人开始时间: 2016年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 116
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
入选标准
- •-Have histological or cytological diagnosis of ED-SCLC and received a prior platinum-based regimen. Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression >= 90 days after the last dose of platinum. Cohort 2 must either have had an objective response to prior platinum based therapy or had progression < 90 days after the last dose of platinum
- •-Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •-Have at least 1 measurable lesion using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •-Have adequate organ function, including:
- •Hematologic: Absolute Neutrophil Count (ANC) >= 1.5x 10^9/L, platelets >= 100 x 10^9/L, Hemoglobin >= 8 g/dL or >=5 mmol
- •Hepatic: direct bilirubin <= 1.5 x ULN, ALT and AST <= 2.5 x ULN or <= 5 x ULN (if the liver has involvement)
- •Renal: Serum creatinine, or measured creatinine clearance, or calculated creatine clearance (using the Chronic Kidney Disease Epidemiology Collaboration (CKP-EPI) equation) < 1.5 x ULN or >= 50 mL/min/1.73 m^2
- •-Men must be sterile or agree to use an effective method of birth control during the study and for at least 12 weeks following the last dose of LY2606368
- •-Women must have a negative serum pregnancy test at screening, have another negative urine pregnancy test within 7 days prior to the first dose of LY2606368, and agree to use a highly effective method of birth control during the study and for 12 weeks following the last dose of LY2606368. Women on study must also not breastfeed.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •-Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
- •-Have symptomatic central nervous system (CNS) malignancy or metastasis.
- •-Have a second primary malignancy that may affect the results of the study (investigator and study sponsor discretion)
- •-Have previously completed or withdrawn from this study or any other study investigating LY2606368 or a CHK 1 Inhibitor
- •-Have serious pre-existing medical conditions (left to the discretion of the investigator)
- •-Have a serious cardiac condition
- •-Have QTc interval of > 470 msec on more than one screening ECG
- •-Have a family history of long QT-syndrome
- •-Have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C
研究者
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