Carcinoma, Renal Cell
Conditions
Brief summary
This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with advanced (unresectable, recurrent or metastatic) RCC * Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy * Patients with an ECOG performance status of 0-2 * Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib * Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice
Exclusion criteria
* Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial * Patients who have participated in any other sorafenib trial * Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry * Life expectancy of less than two months * Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0 * Patients with active coronary artery disease or ischemia * Patients with Child-Pugh class C hepatic impairment * Patients with severe renal impairment or who require dialysis * Patients with active uncontrolled hypertension * Patients with recent or active bleeding diathesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety parameters | From signing consent to 30 days after last dose of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Limited radiological evaluations | At baseline, than every 8 weeks after start of sorafenib |
Countries
Canada, United States
Outcome results
None listed