NL-OMON40353尚未招募2 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
Astra Zeneca0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
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 99（—）
入选标准
- •* Provision of informed consent
- •* Male and female patients
- •* Aged at least 18 years
- •* Histological or cytological confirmation of locally advanced or metastatic non small cell lung cancer
- •* Prospective confirmation of KRAS mutation negative status as determined using the cobas KRAS mutation Test via an AstraZeneca 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
- •* WHO Performance status 0-1
- •* At least one evaluable lesion
- •* Serum creatinin clearance >50 mL/min
- •* Negative pregnancy test or postmenopausal
- •* Patients should be able to swallow capsules
排除标准
- •- Mixed small cell and non-small cell lung cancer histology;- Received >1 prior anti-cancer drug regimen for advanced or metatstatic NSCLC;- Having received an investigational drug or any other systemic anti-cancer therapy within 30 days of starting treatment or within five half-lives of the compound;- Other concomitant anti-cancer therapy agents except steroids;- Prior treatment with a MEK inhibitor or any docetaxel-containing regimen;- Sympotomatic brain metastases or spinal cord compression. Patients with asymptomatic brain metastasis or treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study are eligible;- Laboratory values as listed below:
- •* ANC <1.5 x 109/L (1500 per mm3)
- •* Platelets <100 x 109/L (100.000 per mm3)
- •* Haemoglobin < 9.0 g/dL
- •* Serum bilirubin > 1.5 x Upper Limit of Normal
- •* AST or ALT in patients with no liver metastasis: >2.5 x ULN
- •* AST or ALT in patients with liver metastasis: >5 x ULN
- •* AST or ALT > 3.5 x ULN and <5 x ULN in patients with liver metastasis and ALP > 6 x ULN;- Cardiac conditions as follows:
- •* Uncontrolled hypertension (BP >150/95 mmHg)
- •* Acute coronary syndrome within 6 months prior to starting treatment
- •* Angina Canadian Cardiovascular Society grade II-IV
- •* Symptomatic heart failure
- •* Prior or current cardiomyopathy
- •* Baseline LVEF < 55% by echocardiography or MUGA
- •* Several valvular heart disease
- •* Atrial fibrilation with a ventricular rate >100 bpm on ECG at rest;* Any evidence of severe uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant including hepatitis B, C and HIV;* Refractory nausea and vomiting, chronic gastrointestinal diseases or significant bowel resection that would preclude adequate absorption;- Ophthalmologic conditions:
- •* Current or past history of central serous retinopathy
- •* Current or past history of retinal vein occlusion
- •* Intraocular pressure > 21 mmHg or uncontrolled glaucoma
研究者
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