None listed
Conditions
Interventions
All patients will be randomised to receive either BAY 43-9006 400 mg (2x200 mg tablets) or matching placebo (2 tablets) administered orally twice daily in combination with Best Supportive Care.
The Treatment Period for the study drug will include dosing twice daily in an uninterrupted schedule, the treatment period will be divided into 6 week cycles for the first 24 weeks of treatment. Cycles beyond 24 weeks of treatment will be 8 weeks in duration. Treatment will continue until unacceptable
All patients will be randomised to receive either BAY 43-9006 400 mg (2x200 mg tablets) or matching placebo (2 tablets) administered orally twice daily in combination with Best Supportive Care. The Treatment Period for the study drug will include dosing twice daily in an uninterrupted schedule, the treatment period will be divided into 6 week cycles for the first 24 weeks of treatment. Cycles beyond 24 weeks of treatment will be 8 weeks in duration. Treatment will continue until unacceptable toxicity thought to be related to the study drug and which requires discontinuation of drug is found or consent is withdrawn. Once a patient progresses, the patient may be unblinded and given the opportunity to continue on BAY 43-9006.
Sponsors
Bayer Australia Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have a life expectancy of at least 12 weeksPatients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients must have had only one prior systemic therapy for advanced disease on which the patient progressed. Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumours (RECIST) Patients with Intermediate or low risk per the Motzer score.Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1. Adequate hepatic function.Amylase and lipase <1.5 x the upper limit of normal.Serum creatinine <2.0 x the upper limit of normal. PT or INR and PTT <1.5 x upper limit of normal.
Exclusion criteria
Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumours [Ta, Tis and T1] or other malignancies curatively treated > 2 years prior to entry). Patients who completed their prior systemic treatment regimen less than 30 days or greater than 8 months prior to randomisation.Cardiac arrhythmias, symptomatic coronary artery disease or ischaemia or congestive heart failure. Active clinically serious bacterial or fungal infections.Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or CKnown history or presence of metastatic brain or meningeal tumours.Patients with seizure disorder requiring medication.History of organ allograftSubstance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.Patients with "high" risk per Motzer criteria.Known or suspected allergy to the investigational agent or any agent given in association with this trial.Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.Pregnant or breast-feeding patients.
Outcome results
None listed