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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CP-4055 5mg/mL for infusion, dose: 200 mg/m2/day, schedule d1-5 q4w, 30 minutes IV infusion
Sorafenib 200 mg tablets, dose: 400 mg/day, daily dosing
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Cancer Therapy and Research Center, Institute for Drug Development
San Antonio, Texas, United States
The Norwegian Radium Hospital
Oslo, Norway
Lund University Hospital
Lund, Sweden
• Objective tumour response
Time frame: October 2008
• Time to progression
Time frame: October 2008
• Duration of tumour response
Time frame: October 2008
• Safety and tolerability of treatment
Time frame: October 2008
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Umeå University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden