A Randomized Phase 2 Study of LY2181308 in Combination with Docetaxel versus Docetaxel in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer who Were Previously Treated with First Line Chemotherapy - JACW

Eli Lilly and Company0 个研究点目标入组 180 人开始时间: 2010年1月27日最近更新: 2013年7月15日

试验速览

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•Patients with non-small cell lung cancer with locally or advanced metastatic disease(Stage IIIB or IV at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy
•Measureable disease as defined by response evaluation criteria in solid tumors (RECIST)
•ECOG Performance status of 0 to 1
•Must make available any existing tumor tissue from the primary biopsy
•Patients with prior radiation may be eligible if they meet certain criteria
•Adequate bone marrow reserve and organ functioning
•Women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period. Must not be breastfeeding
•Men must comply with a contraceptive regimen during and for 6 months after the treatment period
•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

•Currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. Patients may be permitted to enter treatment before the 30 day waiting period in special circumstances
•Pregnant or breastfeeding
•Serious concomitant systemic disorders that would compromise the safety of the patient or the patient's ability to complete the study
•Second primary malignancy that could affect compliance with the protocol or interpretation of the study results
•Known allergy or hypersensitivity to docetaxel, taxanes, LY2181308, oligonucleotides, or any component of the formulations
•Patients with documented central nervous system or brain metastasis at the time of study entry
•Pre-existing neuropathy equivalent to a common terminology criteria for adverse events(CTCAE)code greater than or equal to 2

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