Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma

Exclusion Criteria

• •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
• •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