A Multicentre, Dose Finding, Phase II Study of CP-4055 in Combination With Sorafenib in Patients With Metastatic Malignant Melanoma
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