Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer (COMET-2)
|ClinicalTrials.gov Identifier: NCT01522443|
Recruitment Status : Terminated (Stopped after the outcome of cabozantinib Phase 3 CRPC study XL184-307.)
First Posted : January 31, 2012
Last Update Posted : February 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms||Drug: cabozantinib Drug: mitoxantrone Drug: prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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.
- Confirmed pain response at Week 12 durable since Week 6 [ Time Frame: Week 6 and 12 ]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 ]Bone scans will be evaluated by an independent radiology facility for response
- Overall survival [ Time Frame: through 28 months after study start ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522443
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