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

Phase 2

Completed

Brief Summary: Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until complete response or disease worsening/progressing.

Detailed Description: This is a multicentre clinical study conducted in the USA and in Europe. It is an open label study designed to investigate objective tumor response, the time to progression (TTP) and the duration of tumor response in patients with metastatic malignant melanoma when treated with CP-4055 in combination with sorafenib (Nexavar®). The safety and tolerability of the treatment will also be assessed.

Recruitment & Eligibility

Inclusion Criteria

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
Measurable disease according to Response Criteria In Solid Tumors (RECIST)
Performance Status 0 - 1 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
Age 18 years or more
Life expectancy > 3 months
Signed informed consent
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
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
Adequate haematological and biological functions

Exclusion Criteria

Known brain metastases
Diagnosis of ocular malignant melanoma
Radiotherapy to more than 30 % of bone marrow
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Requirement of concomitant treatment with a non-permitted medication:
- Alternative drugs
- High doses of vitamins
History of allergic reactions to ara-C or egg
History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients
Known positive status for HIV and/or hepatitis B or C
Drug and/or alcohol abuse
Any reason why, in the investigator's opinion, the patient should not participate
Prior treatment with CP-4055 and/or sorafenib
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
Condition that impairs ability to swallow pills
Tendency of bleeding

Primary Outcome Measures

Name	Time	Method
• Objective tumour response	October 2008

Secondary Outcome Measures

Name	Time	Method
• Time to progression	October 2008
• Duration of tumour response	October 2008
• Safety and tolerability of treatment	October 2008

Locations (6): Umeå University Hospital
🇸🇪
Umeå, Sweden
Cancer Therapy and Research Center, Institute for Drug Development
🇺🇸
San Antonio, Texas, United States
Lund University Hospital
🇸🇪
Lund, Sweden
University of Pittsburgh Cancer Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
Uppsala University Hospital
🇸🇪
Uppsala, Sweden
The Norwegian Radium Hospital
🇳🇴
Oslo, Norway