EUCTR2007-000915-28-SE进行中（未招募）不适用
A multicentre, dose finding, phase II Study of CP-4055 in combination with Sorafenib in patients with metastatic malignant melanoma - CP4055-203
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1. Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have or have not undergone prior bio- and/or chemotherapy for treatment of melanoma
- •2. Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- •3. Performance Status 0 – 1 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.
- •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 less than or equal to 2.5 times institutional upper limit of normal (ULN). If liver metastases, less than or equal to 5 times institutional ULN
- •b. Serum bilirubin and alkaline phosphatase less than or equal to 1.5 times institutional ULN
- •Renal function:
- •Creatinine less than 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. Diagnosis of ocular malignant melanoma
- •3. Radiotherapy to more than 30 % of bone marrow
- •4. Participation in another therapeutic Clinical Study within 30 days of enrolment or during this Clinical Study
- •5. Requirement of concomitant treatment with a non-permitted medication:
- •Alternative drugs
- •High doses of vitamins
- •Antikoagulant medication, i.e. Marevan, Coumarin, Jantovan, and Waran (warfarin)
- •6. History of allergic reactions to Ara-C or egg
- •7. History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
- •8.Presence of any serious concomitant systemic disorders incompatible with the Clinical Study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- •9. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
- •10. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
- •11. Known positive status for HIV and/or hepatitis B or C
- •12. Drug and/or alcohol abuse
- •13. Any reason why, in the Investigator’s opinion, the patient should not participate
- •14. Prior treatment with CP-4055 and/or sorafenib
- •15. Significant history of cardiac disease, including any of the following:
- •Uncontrolled hypertension
- •Unstable angina pectoris
- •Congestive heart failure
- •Myocardial infarction within the past 6 months
- •Unstable ventricular arrhythmia
- •Other cardiac arrhythmia
- •16. Condition that impairs ability to swallow pills
- •17. Tendency of bleeding
研究者
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