PER-037-09已完成未知
Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
入选标准
- •Histologically or cytologically confirmed diagnosis of non-small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
- •Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease
- •No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed =12 months prior to randomization
- •Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved to CTC Grade 1 (NCI CTCAE v3.0)
- •Age =18 years
- •ECOG performance status (PS) 0 or 1
- •Adequate organ function as determine by the following criteria: a. Absolute neutrophil count (ANC) =1.5 x 109/L. b. Platelet count =75 x 109/L. c. Hemoglobin =8 g/dl. d. Serum creatinine =1.5 x upper limit of normal (ULN). e. Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) =5 x ULN, or =10 x ULN if liver abnormalities are due to underlying malignancy. f. Total bilirubin =1.25 x ULN
- •Female patients may not be pregnant or nursing. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 5 months thereafter.
- •Written, voluntary informed consent must be provided
- •Patients with symptomatic central nervous system (CNS) metastases are not permitted. Patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases. Patients with known, asymptomatic CNS lesions are permitted. Patients with stable, treated brain metastasis (e.g. whole brain radiation therapy or similar) are permitted (off steroid medication)
- •No acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study
排除标准
- •Patients with a primary histology of adenocarcinoma NSCLC and those with unknown or unspecified (Not otherwise specified) NSCLC histology will be excluded
- •Patients with symptomatic central nervous system (CNS) metastases are not permitted.
- •Enrollment in another therapeutic clinical trial is not permitted
- •Previous or concurrent therapy with any IGF1R inhibitor, growth hormone agonist or antagonist is not permitted
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