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NCT01076010 · ClinicalTrials.gov registry record · Phase 3
An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301).
A Phase 3 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 277
- Enrollment target
NCT01076010: Completed Phase 3 study, sponsored by AVEO Pharmaceuticals.
NCT01076010 is a Phase 3 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 277 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01076010, a Phase 3 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 277 participants
- Enrollment target
Study Summary
Open-label, multi-center extension treatment protocol to allow access to tivozanib and sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of disease will receive a tivozanib dose of 1.5 mg/day. Eligible subjects who were randomized to tivozanib or sorafenib in AV-951-09-301, and displayed clinical benefit and acceptable tolerability to treatment, will continue to receive tivozanib or sorafenib at the same dose and schedule as in AV-951-09-301.
Primary Outcome
Number of days subjects received treatment who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Interventions
- DRUG Sorafenib
- DRUG Tivozanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01076010 record still lists
NCT01076010 is an interventional study that assigns participants to a tested intervention. The registered 277 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT01076010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01076010 about?
NCT01076010 is a clinical study titled "An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301).". Open-label, multi-center extension treatment protocol to allow access to tivozanib and sorafenib for subjects who have participated on the AV-951-09-301 protocol. Eligible subjects who were randomized to receive sorafenib on AV-951-09-301 and had documented progression of disease will receive a tivo...
What is the current status of trial NCT01076010?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 277 participants. The study started on 2010-03. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01076010?
The interventions under investigation include: Sorafenib (DRUG), Tivozanib (DRUG).
Who is sponsoring clinical trial NCT01076010?
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 NCT01076010's enrollment target sits among peer trials
277 1202nd of 2000 higher than 799 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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