A Phase 3, randomized, double-blind, controlled trial of cabozantinib (XL184) vs. mitoxantrone plus prednisone in men with previously treated symptomatic castration resistant prostate cancer
The purpose of this study is to find out if cabozantinib is effective in reducing pain compared with mitoxantrone plus prednisone. In order to see if cabozantinib is effective, your level of pain will be followed. This study will also examine how safe cabozantinib is and how well people with an advanced form of prostae cancer tolerate cabozantinib.
You must have a diagnosis of castrate resistant prostate cancer (with testosterone levels less then 50ng/dL within 28 days before starting the study). The person must have evidence of bone metastasis from your prostate cancer as identified by bone scan. You must also be having pain from your bone metastasis that requires pain management with narcotics. The average daily pain intensity must be between 8-10. You or the patient must be on a long acting narcotic taken for chronic pain and one short acting pain pill for breakthrough pain. You also must have a prior history of docetaxel chemotherapy and either abiraterone or MDV3100. Your routine bloodwork must indicate normal organ function, a normal heart scan. One must be in agreement to use contraception to prevent pregancy if you or your partner is fertile. You are not eligible if you have received radiation within 4 weeks of study inclusion. The patient also may not be on certain medications for depression or coumadin. Blood pressure must be controlled with hypertensive drugs and no surgeries within 1-6 months prior to start of study. Your physican and study nurse will review your health history.
This study compares two treatment arms after you complete all screening tests and a qualifing run in stage where you keep a record of your pain management pills for 7 days prior to starting the study drugs: Arm A: Oral cabozantinib (60mg)once daily and mitoxantrone-matched placebo infusion every 3 weeks (a maximum of 10 infusions will be given) plus oral prednisone-matched placebo twice daily. Arm B: Mitoxantrone infusion (12mg/m2) every 3 weeks (maximum of 10 infusions) plus oral prednisone (5mg) twice a day and oral cabozantinib-matched placebo every day. You and your study team will not know which treatment arm you are getting. We will document your pain medication and obtain a PSA every 3 weeks as well as imaging of your cancer with CT and Bone scans every 12 weeks to see how the treatment is effecting your cancer. You may stop the study at any time point, but we do need you to return for all safety follow ups to monitor your health.
12/13/2013 04:02 AM