EUCTR2009-012040-16-BG进行中（未招募）不适用
An open-label, randomized, controlled, multi-center, Phase I/II trial investigating 2 EMD 525797 doses in combination with cetuximab + irinotecan versus cetuximab + irinotecan alone, as second-line treatment for subjects with k-ras wild type (WT) metastatic colorectal cancer (mCRC). Subjects with k-ras WT mCRC will be eligible for enrollment if they are refractory to or progressive after first-line chemotherapy with an oxaliplatin-containing therapeutic regimen.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 237
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
- •Signed and dated written informed consent prior to any specific trial procedure and the ability to comply with the trial and follow-up procedures;
- •Age =18 years of male or female gender;
- •Subjects with histologically-confirmed k-ras WT CRC with documented distant metastasis;
- •Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease;
- •Failed an oxaliplatin regimen for metastatic disease. Failure is defined as either PD (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen, or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing
- •retreatment;
- •At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST (Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as
- •=2 cm by conventional techniques or =1 cm by spiral CT scan;
- •ECOG performance status 0-1, or KPS =80%;
- •Acceptable laboratory parameters including ANC
- •=1.5 x 10E9/L, platelets =100 x 109/L, hemoglobin =9 g/dL (without transfusions), bilirubin =1.5 x ULN, ASAT =5 x ULN, ALAT =5 x ULN, serum creatinine =1.25 x ULN and/or creatinine clearance =50 ml/min, PT, INR, and PTT within normal limits and sodium and potassium within normal limits or =10% above or below
- •(supplementation permitted);
- •Effective contraception for both male and female subjects if the risk of conception exists.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment in another clinical trial within the past 30 days or previous treatment with any inhibitor of EGFR;
- •Known brain metastasis and/or leptomeningeal disease;
- •Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry, planned major surgery during the trial;
- •Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed);
- •Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), or clinically relevant cardiomyopathy;
- •Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg under resting conditions;
- •History of myocardial infarction in the last 12 months, or a high risk of uncontrolled
- •arrhythmia, coagulation disorder associated with bleeding or recurrent thrombotic events, recent peptic ulcer disease (endoscopically proven) within 6 months of trial treatment start, chronic inflammatory bowel disease, or acute/chronic ileus;
- •Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection;
- •Presence of any contra-indications or known hypersensitivity to treatment with EMD 525797, cetuximab, and irinotecan, or to any of the excipients of these drugs;
- •Pregnancy or lactation period;
- •Concurrent treatment with a non-permitted drug;
- •Previous malignancy other than CRC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix;
- •Medical or psychological conditions that would not permit the subject to complete the trial or sign informed consent;
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who are suffering or have suffered from such;
- •Legal incapacity or limited legal capacity;
- •Significant disease which, in the Investigator’s opinion, would exclude the subject from the trial.
研究者
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