NCT00044564

Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Bay 59-8862	75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal

Timeline

• Start date: 2001-12-01
• Completion: 2003-01-01
• First posted: 2002-09-04
• Last updated: 2014-12-19

Locations

29 sites across 6 countries: United States, Canada, France, Germany, Netherlands, United Kingdom