None listed
Conditions
Brief summary
This is a non-randomised, open-label treatment protocol for patients with advanced renal cell carcinoma, who received previous systemic therapy for advanced disease, and who do not have access to or are not eligible for other clinical trials with sorafenib (BAY 43-9006). Safety data and limited efficacy data will be collected.
Interventions
The objective of this study is to make BAY 43-9006 (sorafenib) available for patients with advanced renal cell carcinoma (RCC), who failed prior systemic therapy for advanced disease (i. e., require second-line treatment), and who do not have access to or are not eligible for other clinical trials with BAY 43-9006. In addition, safety data and limited efficacy data will be collected.
Patients will be treated with 400 mg oral BAY 43-9006 twice a day. Patients in this protocol may continue to be
The objective of this study is to make BAY 43-9006 (sorafenib) available for patients with advanced renal cell carcinoma (RCC), who failed prior systemic therapy for advanced disease (i. e., require second-line treatment), and who do not have access to or are not eligible for other clinical trials with BAY 43-9006. In addition, safety data and limited efficacy data will be collected. Patients will be treated with 400 mg oral BAY 43-9006 twice a day. Patients in this protocol may continue to be treated with BAY 43-9006 as a single agent until any of the following criteria for drug or protocol discontinuation is reached: a. Progression of disease. b. The patient is unlikely to benefit from further treatment with BAY 43-9006 as judged by the Investigator. c. Intolerable toxicity of the drug. d. Withdrawal of consent for any reason. It is the intention to continue to recruit patients into the protocol until BAY 43-9006 is registered within Australia by the TGA. Patients, who are enrolled in this study at the time point, when BAY 43-9006 is approved by the Therapeutic Goods Administration (TGA), will continue to be treated in this study.
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Exclusion criteria
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.
Outcome results
None listed