Status and phase
Conditions
Treatments
About
The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment for patients - unsuitable for another approved first line therapy - with advanced RCC in the Middle East Region.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
Patients who have a life expectancy of less than 2 months.
Patients with metastatic brain or meningeal tumours.
Patients are excluded who require any of the following:
Non-measurable disease according to RECIST.
Concomitant St. John's Wort (Hypericum perforatum).
Warfarin (or similar medication) is allowed.
Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study).
Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45 - 0.47 second).
Patients with active coronary artery disease or ischemia.
Patients with Child-Pugh class C hepatic impairment.
Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
Patients with active uncontrolled hypertension.
Patients with recent or active bleeding diathesis.
Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
Primary purpose
Allocation
Interventional model
Masking
75 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal