EUCTR2009-017871-13-PL进行中（未招募）不适用
A multicenter phase II study to evaluate safety and efficacy of glutadon once weekly (GDO) in patients with metastatic colorectal cancer resistant or intolerable to approved chemo- and molecular-targeted therapies
ew Medical Enzymes AG0 个研究点开始时间: 2010年4月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Age = 18 years at visit 1 (day -3)
- •Histologically confirmed diagnosis of colorectal cancer that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent
- •Prior treatment with a fluoropyrimidine (5-fluorouracil and/or capecitabine), oxaliplatin, irinotecan or documented intolerance or ineligibility to the drugs
- •K-RAS mutation or previous therapy with EGFR antagonists (e.g. cetuximab or panitumumab)
- •At least one measurable site of disease on CT/MRI scan at screening
- •ECOG Performance Status of 0 or 1
- •Patients must have normal organ and marrow function:
- •1.White blood cell count (WBC) = 3.5x 109/L;
- •2.Platelets = 100 x 109/L; Hb > 9 g/dl
- •3.ALT and AST = 2.5 x upper limit of normal (ULN) or = 5.0 x ULN if considered due to tumor;
- •4.Alkaline phosphatase = 2.5 x ULN unless considered due to tumor;
- •5.Serum bilirubin = 1.5 x ULN;
- •6.Serum lipase and amylase = 1.5 x ULN or = 5.0 x ULN if considered due to tumor;
- •7.Serum creatinine = 1.5 x ULN or 24-hour creatinine clearance = 50 ml/min. (calculated creatinine clearance using Cockroft formula is acceptable)
- •Ability to understand and willingness to sign a written informed consent
- •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
- •Patients had > 3 previous systemic therapies for metastatic disease
- •Prior treatment with glutadon, PEG-PGA or DON
- •Known hypersensitivity to PEG-PGA and/or DON
- •Treatment with any cytotoxic and/or investigational cytotoxic drug = 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1 (day -3)
- •Previous malignancy (other than colorectal cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
- •Impaired cardiac function defined as congestive heart failure NYHA > class II, any clinically significant brady- or tachycardia, myocardial infarction within 12 months prior to Visit 1, or any other clinically significant heart disease (e.g., unstable angina or uncontrolled hypertension)
- •Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- •Abnormal electrolyte (Serum sodium, potassium and calcium) values that are clinically significant in opinion of the investigator.
- •Patients who have undergone major surgery = 2 weeks prior to Visit 1 (day -3) or who have not recovered from side effects of such therapy
- •Patients who have received wide field radiotherapy = 4 weeks or limited field radiation for palliation < 2 weeks prior to Visit 1 (day -3) or who have not recovered from side effects of such therapy
- •Patients who are pregnant or breast feeding
- •Life expectancy of < 3 months in opinion of the investigator
- •Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception from the start of treatment up 6 months after end of treatment.
- •Known CNS-metastases
- •Known HIV-infection
- •Patients with a history of severe allergy or hypersensitivity
- •History of seizure disorders or central nervous system disorders
- •Uncontrolled nausea and vomiting
- •Not well or uncontrolled diabetes mellitus in opinion of the investigator
- •Patients unwilling or unable to comply with the protocol
研究者
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