NCT01522443

Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Exelixis · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases. This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Conditions

• Prostate Cancer
• Castration Resistant Prostate Cancer
• Pain
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	cabozantinib	Tablets taken orally once daily.
DRUG	mitoxantrone	Given by IV once every 3 weeks.
DRUG	prednisone	Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-10-01
• Completion: 2015-01-13
• First posted: 2012-01-31
• Last updated: 2018-05-23
• Results posted: 2018-05-23

Locations

82 sites across 5 countries: United States, Australia, Canada, Ireland, United Kingdom