NCT01101334已完成2 期
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 17
- 主要终点
- Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
研究概览
简要总结
This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.
The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIB or IV NSCLC.
- •Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy.
- •Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
- •≥ 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Adequate organ and bone marrow function.
- •Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade ≤
- •Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment.
排除标准
- •Treatment with anticancer therapy within 3 weeks before study treatment.
- •Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).
- •Administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.
- •Current need for concomitant use of other TZDs during the study.
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.
- •History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
- •Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
- •Pregnant or breast feeding.
- •Prior treatment with epidermal growth factor receptor (EGFR) inhibitors.
研究组 & 干预措施
CS-7017 plus erlotinib
Experimental
干预措施: CS-7017 (Drug)
CS-7017 plus erlotinib
Experimental
干预措施: erlotinib (Drug)
erlotinib
Active Comparator
干预措施: erlotinib (Drug)
结局指标
主要结局
Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
时间窗: Baseline to disease progression or death, up to approximately 2.5 years
Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.
次要结局
- Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy(Baseline to death, up to approximately 2.5 years)
- Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy(Baseline to disease progression or death, up to approximately 2.5 years)
- Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy(Baseline to 30 days after last dose, up to approximately 2.5 years)
研究者
研究点 (17)
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