A Phase II, Multicenter, Open-Label Study of YM155 in Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC) Who Have Failed One or Two Prior Lines of Therapy, at Least One of Which Contained a Platinum Agent.

Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V. by August 2005)0 个研究点目标入组 60 人开始时间: 2005年9月19日最近更新: 2020年7月27日

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: 60

研究概览入排标准研究者记录与标识符相似试验

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. Male or female patient of ³18 years,
•2. Histologically or cytologically confirmed locally advanced or metastatic Non-Small Cell Lung Cancer, which is stage IIIB or stage IV disease not curable with surgery or radiotherapy at study entry,
•3. Patient has recurrent or refractory disease following 1 or 2 prior chemotherapy regimens, one of which must have included a platinum agent (unless contraindicated). In addition, EGFR TKI therapy is allowed,
•4. Patient has measurable disease, defined as at least 1 target lesion according to the RECIST criteria (see definition in Appendix 4),
•5. ECOG performance status 0-2,
•6. Life expectancy greater than 12 weeks,
•7. Willingness to comply with all procedures and assessments,
•8. Written informed consent has been obtained.
•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. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 4 weeks prior to the start of treatment (6 weeks for nitrosoureas or mitomycin C, or other agents known to cause prolonged marrow suppression, and 2 weeks for palliative external radiotherapy) or planned to be delivered during the study,
•2. Unresolved chronic non-hematological toxicity higher than NCI-CTC grade 2 (excluding cases of alopecia),
•3. Extensive radiation therapy within 4 weeks prior to the start of treatment,
•4. Participated in a clinical study involving an investigational drug or device within 4 weeks prior to the start of treatment,
•5. Has metastases to the brain unless the metastases have been appropriately treated with radiation therapy and the patient is neurologically stable and does not require steroids,
•6. Has inadequate bone marrow, renal, and hepatic function as evidenced by:
•a. Absolute neutrophil count (ANC) =1500/mm3 and platelet count =100000/mm3,
•b. Serum creatinine above the upper limit of normal (ULN) or calculated creatinine clearance <60 mL/min at screening,
•c. Total bilirubin =1.5 times the upper limit of normal (ULN) NCI CTC grade 1,
•d. Alanine transaminase (ALT) and aspartate transaminase (AST) =2.5 times ULN (NCI CTCAE Grade 1); if the patient has documented liver metastases and/or hepatoma, ALT and AST =5 times the ULN.
•7. History of other malignancies within past 5 years with the exception of non melanoma skin cancer and cervical carcinoma in situ,
•8. Has a known or suspected diagnosis of hepatitis B surface antigen (HbsAg) or hepatitis C antibody,
•9. Has a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS) or tested seropositive for human immunodeficiency virus (HIV) antibody or antigen at screening,
•10. Had major surgery within the past 21 days prior to the start of treatment,
•11. Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would limit compliance with study requirements,
•12. Any clinical condition, which, in the opinion of the investigator, would not allow safe conduct of the study.

研究者

发起方

Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V. by August 2005)

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