EUCTR2006-006766-41-GB进行中（未招募）1 期
A phase II Clinical Study of CP-4055 as second line therapy in patients with advanced colorectal cancer - CP4055-202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
入选标准
- •1. Patients with histologically or cytologically confirmed metastatic colorectalcancer who have failed a first line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) (with or without bevazumiab)
- •2. Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- •3. Performance Status 0 – 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- •4. Age 18 years or more
- •5. Life expectancy > 3 months
- •6. Signed informed consent
- •7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
- •8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
- •9. Adequate haematological and biological functions:
- •Bone marrow function:
- •a. Neutrophils above or equal to 1.5 x 109/L
- •b. Platelets above or equal to 100 x 109/L
- •c. Hb above or equal to 10 g/dL
- •Hepatic function:
- •a. AST/ALT below or equal to 2.5 times institutional upper limit of normal (ULN). If liver metastases, below or equal to 5 times institutional ULN
- •b. Serum bilirubin below or equal to 1.5 times institutional ULN
- •Renal function:
- •Creatinine below or equal to 1.5 times institutional ULN
- •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
- •1. Known brain metastases
- •2. Radiotherapy to more than 30 % of bone marrow
- •3. Participation in another therapeutic Clinical Study within 30 days of enrolment or during this Clinical Study
- •4. Requirement of concomitant treatment with a non-permitted medication:
- •Alternative drugs
- •High doses of vitamins
- •5. History of allergic reactions to Ara-C or egg
- •6. Presence of any serious concomitant systemic disorders incompatible with the Clinical Study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- •7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
- •8. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
- •9. Known positive status for HIV and/or hepatitis B or C
- •10. Drug and/or alcohol abuse
- •11. Any reason why, in the Investigator’s opinion, the patient should not participate
研究者
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