EUCTR2012-003622-25-HU进行中（未招募）1 期
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB – IV) SELECT-2
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Provision of signed, written and dated informed consent prior to any
- •study specific procedures
- •Male or female, aged 18 years or older
- •Histological or cytological confirmation of locally advanced or metastatic
- •NSCLC (IIIB-IV)
- •Prospective confirmation of KRAS mutation negative status as
- •determined using the COBAS® KRAS Mutation Test (Roche Molecular
- •Systems) via an AZ approved laboratory
- •Failure of 1st line anti-cancer therapy due to radiological documentation
- •of disease progression in advanced disease or subsequent relapse of
- •disease following 1st line therapy
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 157
排除标准
- •Mixed small cell and non-small cell lung cancer histology
- •Received >1 prior anti-cancer drug regimen for advanced or metastatic
- •NSCLC. Patients who develop disease progression while on switch
- •maintenance therapy (maintenance using an agent not in the first-line
- •regimen) will not be eligible.
- •Having received an investigational drug within 30 days of first dose of
- •treatment or within five half-lives of the compound, or have not
- •recovered from side
- •effects of an investigational drug.
- •Receiving or have received systemic anti-cancer therapy within 30 days
- •starting study treatment.
- •Other concomitant anti-cancer therapy agents except steroids.
- •Prior treatment with a MEK inhibitor or any docetaxel-containing
- •regimen (prior treatment with paclitaxel is acceptable)
- •The last radiation therapy within 4 weeks prior to starting study
- •treatment, or limited field of radiation for palliation within 7 days of the
- •first dose of study treatment
研究者
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