A Randomized Phase 2 Study of Erlotinib plus ARQ 197 versus Erlotinib plus Placebo in Previously Treated Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

ArQule Inc.0 个研究点目标入组 154 人2008年2月11日

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注册库

who.int

开始日期

2008年2月11日

结束日期

待定

最后更新

13年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Each patient must meet the following criteria to be enrolled in this study.
•1\. Provide signed and dated informed consent prior to study\-specific screening procedures
•2\. \= 18 years old
•3\. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
•4\. At least one prior chemotherapy other than erlotinib
•5\. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
•6\. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (see Appendix 2\)
•7\. Male or female patients of child\-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
•8\. Females of childbearing potential must have a negative serum pregnancy test
•9\. Aspartate transaminase (AST) and alanine transaminase (ALT) \= 2\.5 × upper limit of normal (ULN) or \= 5 × ULN with metastatic liver disease

•Patients who meet any of the following criteria will be excluded from the study.
•1\. Previously received erlotinib therapy
•2\. Received anti\-tumor treatment for NSCLC within 4 weeks prior to randomization
•3\. Known or suspected central nervous system metastases
•4\. Pregnant or lactating
•5\. Significant gastrointestinal disorder, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn’s disease, ulcerative colitis, extensive gastric resection)
•6\. Unable or unwilling to swallow erlotinib or ARQ 197
•7\. Any contraindication to treatment with ARQ 197 or erlotinib
•8\. Any known hypersensitivity to any of the component of ARQ 197 or erlotinib
•9\. Other malignancies within the last five years, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value \< 0\.2 ng/ml or basal or or squamous cell carcinoma of the skin