An Open-Label, Non-Comparative Expanded Access Study of the Raf-Kinase Inhibitor Sorafenib as a Subsequent to First-Line Therapy in Patients with Advanced Renal Cell Carcinoma
- Conditions
- Advanced renal cell carcinomaCancer - Renal Cell Carcinoma
- Registration Number
- ACTRN12606000140550
- Lead Sponsor
- Austin Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
The patient must provide written informed consent prior to receiving BAY 43-9006.The patient must have advanced Renal Cell Carcinoma.The patient must have failed at least one prior systemic established therapy for advanced RCC, or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC.A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity, if any, prior to study entry.The patient must be, in the Investigator’s opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent.The patient must have an Eastern Cooperative Oncology Group performance status of 0-2.The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy while taking BAY 43-9006. Treatment with bisphosphonates is permitted.Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol.For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks).
Patients who are currently enrolled in or have previously participated in any other BAY 43-9006 trial and who received BAY 43-9006.Patients, who are eligible for or do have access to any other BAY 43-9006 clinical trial as to the knowledge of the Investigator.Patients who have a life expectancy of less than 2 months.Patients with uncontrolled metastatic brain or meningeal tumours. Patientswith prior brain or meningeal metastases that have been adequately treatedand who show no evidence of progression are eligible.Patients are excluded who require any of the following:a. Investigational drug therapy during the treatment with BAY 43-9006 or within 30 days prior to their first dose of BAY 43-9006.b. Concomitant Rifampicin.c. Concomitant St. John’s Wort (Hypericum perforatum).Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time should be performed.Women who are pregnant or breast-feeding. Patients with congestive heart failure greater than New York Heart Association (NYHA) functional class II (symptomatic during ordinary activity).Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE.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.Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be progression of disease[Assessed at monthly visits by appropriate radiological and other procedures according to the local standard of care.]
- Secondary Outcome Measures
Name Time Method nil[nil]