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NCT00920816 · ClinicalTrials.gov registry record · Phase 3
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 492
- Enrollment target
NCT00920816: Completed Phase 3 study, sponsored by Pfizer.
NCT00920816 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 492 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00920816, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 492 participants
- Enrollment target
Study Summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
Primary Outcome
Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease \[PD\]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is \>= 20 percent (%) increase in sum of longest diamete
Interventions
- DRUG Sorafenib
- DRUG Axitinib (AG-013736)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2009-08-25 |
| Est. Completion | 2021-04-29 |
| Phase | Phase 3 |
What the finished NCT00920816 record still lists
NCT00920816 is an interventional study that assigns participants to a tested intervention. The registered 492 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 (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT00920816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00920816 about?
NCT00920816 is a clinical study titled "Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer". The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
What is the current status of trial NCT00920816?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 492 participants. The study started on 2009-08-25. Estimated completion is 2021-04-29.
What interventions are being tested in trial NCT00920816?
The interventions under investigation include: Sorafenib (DRUG), Axitinib (AG-013736) (DRUG).
Who is sponsoring clinical trial NCT00920816?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00920816's enrollment target sits among peer trials
492 780th of 2000 higher than 1,220 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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