XL184-306- Phase 3 study of XL184 vs mitoxantrone & prednisone in CRPC
Research type
Research Study
Full title
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
IRAS ID
103678
Contact name
Johann De Bono
Sponsor organisation
Exelixis, Inc
Eudract number
2012-001426-99
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 double-blind trial of cabozantinib (XL184) versus mitoxantrone plus prednisone in men with previously treated symptomatic castration resistant prostate cancer (CRPC). Bone metastases (spread of cancer to bone) and associated pain are a major cause of illness and death in CRPC patients. The combination therapy of mitoxantrone plus prednisone is currently used in CRPC patients, however, recent results with this treatment showed only a modest reduction in pain. The purpose of this study is to confirm if cabozantinib is safe and will improve pain reduction compared with mitoxantrone plus prednisone in CRPC patients. Study participants will have an equal chance of being in 1 of 2 treatment groups, assigned in a random fashion. Neither patients nor doctors will know which has been assigned: ?½Arm A: Oral cabozantinib (60mg) once daily and mitoxantrone placebo infusion every 3 weeks (maximum 10 infusions) plus oral prednisone placebo twice daily ?½Arm B: Mitoxantrone infusion (12mg/m2) every 3 weeks (maximum 10 infusions) plus oral prednisone (5mg) twice daily and oral cabozantinib placebo once dailyPatients will continue in the study as long as they experience clinical benefit in the investigators opinion, or if they withdraw for another reason such as intolerable side effects. Study visits are performed at least every 3 weeks until all study treatment is permanently discontinued. The duration of the study will vary for each patient, and is expected to be less than a year. Over 2-years, the study would require a maximum of 37 visits. Procedures involved include physical exams, vital signs, electrocardiograms, blood tests, urine tests, X-ray, CT, MRI, bone scans, echocardiograms, MUGA scans and patient questionnaires. This study is sponsored by Exelixis. Approximately 246 patients from 50 sites in North America, Australia, and UK will participate, with approximately 20 patients expected in the UK.
REC name
London - Fulham Research Ethics Committee
REC reference
12/LO/0923
Date of REC Opinion
11 Jul 2012
REC opinion
Further Information Favourable Opinion