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NCT01030783 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma
A Phase 3 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
NCT01030783: Completed Phase 3 study, sponsored by AVEO Pharmaceuticals.
NCT01030783 is a Phase 3 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 517 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01030783, a Phase 3 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
Study Summary
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.
Primary Outcome
Progression-Free Survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.0 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Interventions
- DRUG Sorafenib
- DRUG tivozanib (AV-951)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01030783 record still lists
NCT01030783 is an interventional study that assigns participants to a tested intervention. The registered 517 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT01030783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01030783 about?
NCT01030783 is a clinical study titled "A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma". This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of ...
What is the current status of trial NCT01030783?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2009-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01030783?
The interventions under investigation include: Sorafenib (DRUG), tivozanib (AV-951) (DRUG).
Who is sponsoring clinical trial NCT01030783?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01030783's enrollment target sits among peer trials
517 724th of 2000 higher than 1,277 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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