PER-029-09已完成未知
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic Non Small Cell Lung Cancer (Stage IIIB- IV)
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2009年7月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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 80（—）
- 性别
- All
入选标准
- •Provision of a signed, written and dated consent before performing any specific study procedure.
- •Participants of male or female sex, over 18 years of age.
- •Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV).
- •Failure of 1® line therapy against cancer (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of the disease after 1st line therapy. See Appendix L for more details. See Section 5.2 for specific V line agents not allowed in this study.
- •WHO Functional Status 0 - 1.
- •Patients must be eligible to receive docetaxel treatment according to docetaxel product information (available from Sanofi- Aventis, the manufacturer of docetaxel - see Appendix J for contact details).
- •At least one lesion, not previously irradiated, that can be measured exactly as S10 mm in the longest diameter (LD) with spiral computed tomography (CT) or as 520 mm with conventional techniques (CT, conventional MRI) and that is suitable for exact repeated measurements.
- •Tumor sample confirmed as positive KRAS mutation (Note: The sample must be available after enrollment to be sent to the central laboratory designated by AZ, or the mutation status confirmed locally in a central laboratory accepted by AstraZeneca using a) allele-specific PCR (this includes ARMS ™) or b) direct sequencing).
- •Evidence of postmenopausal status, or negative pregnancy test in urine or serum for premenopausal female patients. Postmenopausal women are defined as follows: natural menopause with menstruations> 1 year ago; or radiation-induced oophorectomy with the last menstruations> 1 year ago; or chemotherapy-induced menopause with an interval of 1 year since the last menstruations; o serum FSH and LH levels and plasma estradiol in the postmenopausal range for the institution; or bilateral oophorectomy or hysterectomy.
- •Serum creatinine clearance> 50 mL / min is already done using the Cockcroft-Gault formula or 24-hour urine collection analysis.
- •Patients should be able to swallow AZD6244 / placebo capsules.
排除标准
- •Participation in the planning and / or conduct of the study (applies to both AstraZeneca staff and staff at the study site).
- •Prior randomization of treatment in the present study.
- •Mixed histology of microcytic and non-small cell lung cancer.
- •Received> 1 previous cancer therapy for advanced or metastatic NSCLC (excluding radiotherapy, see 6V 9 exclusions).
- •Having received an investigational drug within 30 days before admission, or not having recovered from the side effects of an investigational drug.
- •You are receiving or have received systemic cancer therapy within 4 weeks prior to! Start of study treatment (6 weeks for nitrosoureas, mitomycin and suramin).
- •Previous treatment with MEK inhibitor or any regimen containing docetaxel (prior treatment with paclitaxel is acceptable).
- •Any unresolved toxicity> CTCAE Grade 2 of previous cancer therapy, other than alopecia,
- •The last radiation therapy within 4 weeks prior to the start of the study treatment, or limited radiation field for palliation within 2 weeks of the first dose of the study treatment.
- •Recent major surgery within 4 weeks prior to admission to the study (excluding vascular access placement) which would prevent the administration of the study treatment.
- •History of hypersensitivity to AZD6244, docetaxel or any of the excipients of these agents.
- •Cerebral metastasis or compression of the spinal cord unless it is asymptomatic, treated and stable without steroids and anticonvulsants for at least 3 months.
- •Altered laboratory values
- •Cardiac conditions
- •Any evidence of severe or uncontrolled systemic disease, active infection, active hemorrhagic diathesis or renal transplantation, including any known patient suffers from hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- •Resistant nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that could prevent adequate absorption.
- •History of another primary malignancy within 5 years prior to the start of the study treatment, except for squamous or basal cell carcinoma of the skin or cervical cancer treated properly and the disease under study.
- •Female patients who are breastfeeding, or male or female patients with reproductive potential who are not using an effective method of birth control.
- •Clinical criteria by the investigator that the patient should not participate in the study.
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