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NCT01522443 · ClinicalTrials.gov registry record · Phase 3
Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
A Phase 3 study, sponsored by Exelixis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT01522443: Clinical Trial Phase 3 study, sponsored by Exelixis.
NCT01522443 is a Phase 3 study that was terminated before completion, run by Exelixis. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01522443, a Phase 3 study, was terminated before completion, sponsored by Exelixis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG prednisone
- DRUG cabozantinib
- DRUG mitoxantrone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-01-13 |
| Phase | Phase 3 |
Why NCT01522443 stopped before completion
NCT01522443 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which prednisone is the first listed.
NCT01522443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01522443 about?
NCT01522443 is a clinical study titled "Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer". 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 lesio...
What is the current status of trial NCT01522443?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2012-03. Estimated completion is 2015-01-13.
What interventions are being tested in trial NCT01522443?
The interventions under investigation include: prednisone (DRUG), cabozantinib (DRUG), mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT01522443?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01522443's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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