Clinical trial NCT00498836 (phase 2, status: completed)
Conditions: malignant melanoma
ICD codes: C43.0, C43.31, C43.51, C43.9, C43.4, C43.52, C43.10
Drugs: cp-4055, sorafenib (nexavar)
SMILES: [H]\C(CCCCCCCC)=C(\[H])CCCCCCCC(=O)OC[C@@]1([H])O[C@@]([H])(N2C=CC(=N)N=C2O)[C@@]([H])(O)[C@]1([H])O, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histological or cytological confirmed stage IV or unresectable stage III
             non-ocular malignant melanoma who have or have not undergone prior chemotherapy for
             the treatment of melanoma

          2. Measurable disease according to Response Criteria In 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

        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