A Phase III randomised study of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer

Phase 3

Completed

• Conditions: nresectable and /or metastatic renal cell cancer.; Unresectable and /or metastatic renal cell cancer.; Cancer - Kidney

• Registration Number: ACTRN12605000643673
• Lead Sponsor: Bayer Australia Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-14
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 884

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified