PER-113-07已完成未知
A PHASE II / III STUDY OF TREATMENT WITH MK-0646 IN COMBINATION WITH CETUXIMAB AND IRINOTECAN FOR PATIENTS WITH METASTASIC COLORECTAL CANCER
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 8 人开始时间: 2008年1月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 8
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
- 0 至 0（—）
入选标准
- •The patient has histologically or cytologically confirmed colorectal cancer.
- •The patient has at least one measurable lesion greater than or equal to 20 mm.
- •The patient has previously failed regimens containing irinotecan and oxaliplatin and should have evolved within 3 months of completing his last line of therapy with evidence of objective radiological evolution as verified by previous radiological tomography.
- •The patient is male or female, and> 18 years of age on the day of signing the informed consent.
- •The patient has a performance status of 0-1 on the Performance Scale according to the ECOG.
- •The patient has an adequate organ function
- •The potently fertile patient has a serum pregnancy test or p-hCG in urine with a negative result at baseline.
- •The patient, or the legal representative of the patient, has voluntarily accepted to participate by giving their written informed consent.
- •The patient has archival tumor available for analysis in studies with biomarkers.
排除标准
- •The patient has undergone chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to the initial dose in this study or whose toxicities by agents administered 2 weeks before have not disappeared to at least grade 1 or baseline.
- •The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days or 5 half lives of the research agent, including the longest one, from the initial dose of this study.
- •The patient has experienced an intolerable toxicity to irinotecan therapy.
- •The patient has previous exposure to IGF-IR inhibitors or EGFR inhibitors (for example cetuximab).
- •The patient has known metastasis in the CNS and / or carcinomatous meningitis.
- •The patient has a primary tumor to the central nervous system.
- •The patient has a known hypersensitivity to the components of study drugs or their analogues that can not be treated by premedication with antihistamines and steroids.
- •The patient has a current history or evidence of a condition, therapy, or laboratory abnormality that could confuse the results of the study, interfere with the patient´s participation for the entire duration of the study, or the patient does not have the best interest to participate .
- •The patient has a history of previous malignancy with the exception of intraepithelial neoplasia to the cervix; basal cell carcinoma of the skin; carcinoma located in the prostate treated adequately with PSA <1.0; has been subjected to potent curative therapy without evidence of this disease for five years, or is considered low risk to return to go according to his treating physician.
- •The patient has known psychiatric or substance abuse disorders that would interfere with the cooperation with the test requirements.
- •At the time of signing the informed consent, the patient is a regular user (including recreational use) of licit drugs or has had a recent history (within the last year) of drug or alcohol abuse.
- •The patient is pregnant or nursing, or expects to conceive within the projected duration of the study.
- •The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
- •The patient has active Hepatitis B or C known.
- •The patient has ascites or symptomatic pleural effusions. A patient who is clinically stable after treatment for these conditions is already eligible.
- •The patient is simultaneously using growth hormones (GH), or inhibitors of; growth hormone.
研究者
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