A PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PTK787 IN PATIENTS WITH METASTATIC CUTANEOUS MELANOMA

Overview

No summary available.

Registry

who.int

Start Date

May 6, 2009

End Date

April 30, 2009

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Patients with histologically or cytologically confirmed unresectable, metastatic cutaneous melanoma.
•Life expectancy \> 12 weeks.
•Performance status 0, 1 or 2 (ECOG performance scale : Appendix A).
•Presence of 1 or more bidimensionally measurable lesions, either clinically or radiologically (by chest x\-ray, CT or conventional MRI scan as appropriate), using RECIST criteria.
•Age \> 18 years.
•Laboratory parameters:
•Hb \> 10 g/dl, platelets \> 100,000 mm3, WCC \> 3\.0 x109/L, ANC \> 1\.5x109/L
•Bili \< 1\.5 x ULN, Alk phos \< 3 x ULN, transaminases \< 3 x ULN, (or alk phos and transaminases \< 5 if liver metastases are present)
•Cr \< 1\.5 x ULN
•Measured creatinine clearance \> 50 ml/min and total urinary protein \< 500 mg/24 hour .

•Any previous chemotherapy, immunotherapy or investigational agent within the last 4 weeks.
•Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
•Any medical or psychiatric condition which would influence the ability to provide informed consent.
•Patients with a history of renal (eg. glomerulonephritis) or renal vascular disease.
•Acute or chronic active liver disease (e.g., hepatitis, cirrhosis).
•Surgery within 2 weeks of entry on to the study.
•Incomplete recovery from previous surgery or non\-surgical treatment.
•History or presence of central nervous system (CNS) disease i.e., primary brain tumor, malignant seizures, clinically symptomatic CNS metastases or carcinomatous meningitis.
•Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
•Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen;