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临床试验/EUCTR2009-015621-36-BE
EUCTR2009-015621-36-BE进行中（未招募）1 期

A double-blind, randomized, comparative, multicenter, exploratory, and placebo-controlled Phase II trial of FOLFIRI plus MSC1936369B or placebo with a safety run-in part as second-line treatment of metastatic K Ras mutated colorectal cancer subjects

Merck Serona S.A., Geneva, Switzerland0 个研究点目标入组 196 人开始时间: 2010年1月13日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
196
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

  • •Histologically confirmed KRAS mutated colon/rectum cancer.
  • •Subject’s disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidins based chemotherapy with or without bevacizumab.
  • •Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors [RECIST v1.0] (at least one measurable lesion). Complete tumor assessment performed within 14 days prior to first trial drug administration.
  • •Age of subjects at least 18 years.
  • •Subject has read, understood and given informed consent, fully understands requirements of the trial, and is willing to comply with all trial visits and assessments.
  • •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 are defined as: All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.”
  • •Female subjects of childbearing potential and male subjects with female partners 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. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device. The use of
  • •hormonal contraceptives should be avoided in female subjects
  • •of childbearing potential due to possible drug-drug
  • •interaction.
  • •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 121
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 75

排除标准

  • •Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 10^9/L, and/or platelets < 100 x 10^9/L.
  • •Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal) and/or calculated creatinine clearance < 50 mL/min.
  • •Liver function and liver cell integrity 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.
  • •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.
  • •History of difficulty of swallowing, malabsorption or other chronic gastrointestinal 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, or active hepatitis B.
  • •Has received 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.
  • •Has received chemotherapy or any investigational drug in the 4 weeks prior to trial first drug administration.
  • •Has a history of any other significant medical disease such as major gastric or small bowel surgery, or has a psychiatric condition that might impair the subject’s well being or preclude full participation in the trial.
  • •Past or current history (within the last 2 years prior to inclusion) of malignancies except for the indication under this study and curatively treated: basal and squamous cell carcinoma of the skin and in-situ carcinoma of the cervix.
  • •Has significant cardiac conduction abnormalities and/or pacemaker.
  • •Is a pregnant or nursing female.
  • •Has retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis, or history of retinal vein occlusion and/or any medically relevant abnormal findings at the initial ophthalmologic examination.
  • •Other significant disease that in the Investigator’s opinion would exclude the subject from the trial.
  • •Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s).
  • •Legal incapacity or limited legal capacity.

研究者

发起方
Merck Serona S.A., Geneva, Switzerland

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