EUCTR2009-011992-61-FR进行中（未招募）1 期
Phase II randomized trial of MEK inhibitor AS703026 or placebo combined with gemcitabine in chemo-naïve metastatic pancreas cancer subjects
Merck Serono S.A. - Geneva0 个研究点目标入组 141 人开始时间: 2009年9月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 141
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
- •Subject fully understands requirements of the trial, is willing to comply with all trial visits and assessments, has provided written informed consent.
- •Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas and availability of tumor sample (archived or fresh biopsy).
- •Evidence of disease (not necessarily measurable disease) as per complete tumor assessment performed within 28 days prior to trial entry/randomization.
- •Age 18 years and older.
- •Women of childbearing potential must have a negative blood pregnancy test at the screening visit.
- •Willingness to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to, during and four weeks after the last dose trial medication as applicable.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 10^9/L, platelets < 100 x 10^9/L.
- •Renal impairment as evidenced by serum creatinine > 1.5 x upper limit of normal (ULN), and/or calculated creatinine clearance < 60 mL/min.
- •Liver function abnormality as defined by total bilirubin > 1.5 x ULN, or AST/ALT > 2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN.
- •Serum calcium > 1 x ULN.
- •History of central nervous system (CNS) metastases, unless certain prerequisites are met.
- •History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.
- •Known HIV positivity, active hepatitis C, active hepatitis B or signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- •Prior chemotherapy, other than allowed
- •Extensive prior radiotherapy or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed under certain circumstances.
- •History of any other significant medical disease that might impair the subjects well being or preclude full participation in the trial.
- •Significant cardiac conduction abnormalities and/or pacemaker.
- •Pregnant or nursing female subject.
- •Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis or history of retinal vein occlusion.
- •Known hypersensitivity to the AS703026 or gemcitabine.
- •Participation in another clinical trial within the past 28 days.
研究者
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