A phase II Clinical Study of CP-4055 in patients with metastatic melanoma not previous treated with chemotherapy - CP4055-201

Clavis Pharma as0 个研究点目标入组 42 人开始时间: 2005年6月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy (chemotherapy-naive)
•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. 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 = 2.5 times institutional upper limit of normal (ULN). If liver metastases, = 5 times institutional ULN
•b. Serum bilirubin and alkaline phosphatase = 1.5 times institutional ULN
•Renal function:
•Creatinine = 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

•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. Prior immuno- and/or chemotherapy including vaccines for the treatment of melanoma
•6. Requirement of concomitant treatment with a non-permitted medication:
•Alternative drugs
•High doses of vitamins
•7. History of allergic reactions to Ara-C or egg
•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. Any reason why, in the Investigator’s opinion, the patient should not participate
•13. Drug and/or alcohol abuse

发起方

Clavis Pharma as