EUCTR2008-005536-32-AT进行中（未招募）不适用
Phase II double-blind placebo-controlled trial of CY-503 in patients with chemotherapy-refractory metastatic colorectal cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Patients are eligible with diagnosis of measurable metastatic colorectal
- •carcinoma and radiologic documentation of disease progression during or within 3 months after termination of standard chemotherapy (fluoropyrimidine –based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 2nd line therapy due to intolerance or who were refractory or intolerant to the standard
- •treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
- •Austria specific inclusion criteria:
- •According the Austrian Health Care Structure Plan” (ÖSG), become law due
- •to the Regional Health Care Structure Plan of Tyrol (§ 5) by the regional decree
- •LGBl. no. 85/2009, the inclusion of a patient have to be discussed and
- •recommended into the concerned Tumor board, to make sure, that all standard
- •therapies applicable in this case have been exhausted. Furthermore, this is a
- •supporting procedure to consult the investigator regarding the instructions of
- •the inclusion criteria.
- •No chemotherapy within 4 weeks before treatment start
- •No residual significant toxicity (greater than NCI grade 1); in case of peripheral neuropathy: no symptoms of
- •peripheral neuropathy of NCI CTC AE grade 4 within 4 weeks before treatment start.
- •No previous treatment with experimental therapies after standard therapies is allowed.
- •Patients must use effective contraception if of reproductive potential. Females
- •must not be pregnant or lactating.
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0 – 2
- •WBC = 3,000/mm3, absolute neutrophil count (ANC) = 1,500/mm3,
- •platelet count =100,000/mm3.
- •Bilirubin = 2.0 mg/dL (40 µmol/L) (unless due to Gilbert’s syndrome
- •in which case the bilirubin should be =3.5 mg/dL (59.86 µmol/L)), aspartate
- •transaminase (AST)/alanine transaminase (ALT) = 5 × upper
- •limit of normal (ULN); hepatic alkaline phosphatase = 3.0 × ULN
- •Serum creatinine = 2.0 mg/dL (180 µmol/L) or creatinine
- •clearance = 50 ml/min, proteinuria < 2.0 g/24 hr urine collection in
- •patients with a positive urine dipstick for protein.
- •Written informed consent according to ICH-GCP and national laws and regulations
- •prior to receipt of any trial medication or beginning trial procedures.
- •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
- •Evidence of any other malignant disease (with the exception of tumours
- •operatively cured at least 5 years prior to the trial)
- •Known brain metastases
- •Uncontrolled pleural effusions
- •Interstitial pneumonitis or pulmonary fibrosis
- •Severe/ unstable systemic disease or infection and circumstances not permitting
- •trial participation (e.g. alcoholism or substance abuse)
- •Unstable cardiac disease in the last 6 months
- •Use of conventional mistletoe preparations, any immunostimulating substances and/or, monoclonal antibodies
- •within 4 weeks prior to and during the trial. Ongoing therapy with steroids is permitted if the dose is not higher
- •than 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial.
- •Any evidence of or history elicited by the investigator of symptomatic
- •cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months
- •prior to randomization
- •Any history or evidence of pulmonary embolism or thrombophlebitis (including deep
- •vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
- •History of hypersensitivity to mistletoe
- •History of primary immunodeficiency
- •Known human immunodeficiency virus (HIV) or known active viral hepatic infections
- •Prior treatment with CY-503
- •A general medical or psychological condition or behaviour, including substance
- •dependence or abuse that, in the opinion of the investigator, might not permit the
- •patient to complete the trial or sign the informed consent
研究者
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