A Phase II study to evaluate the efficacy and safety of PTK787 in patients with metastatic cutaneous melanoma

Overview

Registry

who.int

Start Date

April 4, 2006

End Date

December 31, 2006

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Life expectancy \>12 weeks
•2\. Performance status 0, 1 or 2 (Eastern Cooperative Oncology Group \[ECOG] performance scale)
•3\. Presence of one or more bi\-dimensionally measurable lesions, either clinically or radiologically (by chest x\-ray, computerised tomography \[CT] or conventional magnetic resonance imaging \[MRI] scan as appropriate) using response evaluation criteria in solid tumors (RECIST) criteria
•4\. Age \>18 years
•5\. Hb \>10 g/dl, platelets \>100,000 mm^3, white cell count (WCC) \>3\.0 x 10^9 /l, absolute neutrophil count (ANC) \>1\.5 x 10^9 /l
•6\. Bilirubin \<1\.5 x upper limit of normal (ULN), alkaline phosphatase \<3 x ULN, transaminases \<3 x ULN, (or alkaline phosphatase and transaminases \<5 if liver metastases are present)
•7\. Creatinine \<1\.5 x ULN
•8\. Measured creatinine clearance \>50 ml/min and total urinary protein \<500 mg per 24 hours
•9\. Written informed consent provided by the patient
•10\. Patients of both genders with reproductive potential not employing an effective method of birth control, barrier contraceptives must be used throughout the trial. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.

•1\. Patients who have received a first line therapy for advanced disease, when the initial response was documented to be disease progression, using RECIST criteria
•2\. Any previous chemotherapy, immunotherapy or investigational agent within the last four weeks
•3\. Any other serious or uncontrolled illness, which in the opinion of the investigator makes it undesirable for the patient to enter the trial
•4\. Any medical or psychiatric condition, which would influence the ability to provide informed consent
•5\. Patients with a history of renal (e.g. glomerulonephritis) or renal vascular disease
•6\. Acute or chronic active liver disease (e.g. hepatitis, cirrhosis)
•7\. Surgery within two weeks of entry into the trial
•8\. Incomplete recovery from previous surgery or non\-surgical treatment
•9\. History or presence of central nervous system (CNS) disease i.e. primary brain tumour, malignant seizures, clinically symptomatic CNS metastases or carcinomatous meningitis
•10\. Any of the following concurrent severe and/or uncontrolled medical conditions, which could compromise participation in the trial: