Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer (COMET-2)
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.
Castration Resistant Prostate Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Confirmed pain response at Week 12 durable since Week 6 [ Time Frame: Week 6 and 12 ] [ Designated as safety issue: No ]Subjects will self-report information on pain and health-related quality of life via an interactive voice recognition system
- Bone scan response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Bone scans will be evaluated by an independent radiology facility for response
- Overall survival [ Time Frame: through 28 months after study start ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
There will be a maximum of 10 infusions for mitoxantrone placebo.
Tablets taken orally once daily.
Active Comparator: Mitoxantrone/prednisone
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
There will be a maximum of 10 infusions for 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.
|Contact: Exelixis Clinical Trials||1-888-393-5494|
|Contact: Backup or International||+1-650-837-7400|
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