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

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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 objectives of the study are to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone. Efficacy will be measured by (1) proportion of subjects with pain response at week 6 confirmed at week 12. (2) Bone scan response at week 12 per IRF (primary analysis designates subjects with soft tissue progression as non-responders). (3) Overall survival

Protocol Number081208
Principal InvestigatorMark Stein
PhasePhase III
ScopeNational
Applicable Disease SitesProstate
Therapies InvolvedTherapy (NOS)
Drugs InvolvedCabozantinib(XL184)
PREDNISONE
MITOXANTRONE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.