Phase II randomized trial of MEKinhibitor MSC1936369B or placebo combined with gemcitabine in metastatic pancreas cancer subjects

Merck Serono S.A. - Geneva0 个研究点目标入组 86 人开始时间: 2009年8月17日最近更新: 2015年8月17日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 86

研究概览入排标准研究者记录与标识符相似试验

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

•1. Subject has provided signed informed consent. Fully understands requirements of the trial and willing to comply with all trial visits and assessments.
•2. Histologically or cytologically confirmed adenocarcinoma of the pancreas with documented distant metastases and availability of tumor sample.
•3. Evidence of disease (not necessarily measurable disease). Complete tumor assessment including chest X ray, CT scan of abdomen and other scans as necessary to document all sites of disease performed within 28 days prior to trial entry/randomization.
•4. Age = 18 years.
•5. Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential is defined as: All female subjects after puberty unless they are post-menopausal for at least two years, or are surgically sterile.”
•6. Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and four weeks after the last dose of trial medication. Male subjects with female partner of childbearing potential must be willing o avoid pregnancy of their partner by using an adequate method of contraception for 2 weeks prior to screening, during and up to 6 months after the last dose trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device. The use of oral contraception is not recommended because of nausea and vomiting potentially induced by the study drugs.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 58
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

排除标准

•1. Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L.
•2. Renal impairment as evidenced by calculated creatinine clearance < 60 mL/min.
•3. 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.
•4. Serum calcium > 1 x ULN.
•5. History of central nervous system (CNS) metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants.
•6. History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
•7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.
•8. 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.
•9. Prior chemotherapy for metastatic disease, however prior chemotherapy will be accepted in the following situations:
•Subjects who received gemcitabine with radiation therapy as a radiosensitizer for locally advanced disease
•Subjects who completed chemotherapy (5-FU or gemcitabine) in adjuvant setting for resectable disease 6 months or more prior to the study entry
•10. Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed if last fraction was completed at least 4 weeks prior to trial entry/randomization.
•11. History of any other significant medical disease such as major gastric or small bowel surgery, recent drainage of significant volumes of ascites or pleural effusion or has other significant disease or a psychiatric condition that might impair the subjects well being or preclude full participation in the trial.
•12. Significant cardiac conduction abnormalities, including QTc prolongation of >480 ms and/or pacemaker.
•13. Pregnant or nursing female subject.
•14. Retinal degenerative disease (Hereditary retinal degeneration or age-related macular degeneration), history of uveitis or history of retinal vein occlusion.
•15. Known hypersensitivity to the MSC1936369B or gemcitabine.
•16. Participation in another clinical trial within the past 28 days.
•17. Has CPK level at baseline NCI CTCAE Grade =2 (i.e., > 2.5 x ULN), and/or has a previous history of myositis or rhabdomyolysis.

研究者

发起方

Merck Serono S.A. - Geneva

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