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
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
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 :||January 13, 2015|
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.
- Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported [ Time Frame: Pain response was measured at Week 6 and Week 12 by self-reports of subjects ]The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.
- Bone Scan Response (BSR) [ Time Frame: BSR was measured at the end of Week 12 as determined by the IRF ]BSR is defined as >=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response.
- Overall Survival (OS) [ Time Frame: OS was measured at the time of randomization until 78 deaths ]OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522443
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