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 193 人2007年12月13日

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注册库

who.int

开始日期

2007年12月13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
•2\. \= 18 years old
•3\. Histologically or cytologically confirmed inoperable locally advanced or metastatic
•(stage IIIB/IV) NSCLC
•4\. \= one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have
•included erlotinib or other EGFR inhibiting agent)
•5\. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
•6\. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (see
•Appendix 2\)

•Patients who meet any of the following criteria will be excluded from the study:
•1\. Previous receipt of erlotinib or other EGFR inhibiting therapy
•2\. Receipt of any anti\-tumor treatment for NSCLC within 4 weeks (2 weeks for
•radiotherapy) prior to the start of designated treatment
•3\. Documented major surgical procedure within 4 weeks prior to randomization.
•4\. Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti\-epileptics, or
•other symptom\-relieving medications
•5\. Pregnant, breast\-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
•6\. Significant gastrointestinal disorder that, in opinion of Investigator, could interfere
•with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn’s disease, small or large