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NCT02627963 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
A Phase 3 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT02627963 is a Phase 3 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 350 participants.
The verdict
NCT02627963, a Phase 3 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study Summary
This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor \[programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor\] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent). All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. Pharmacokinetic (PK) analyses are also included in study.
Interventions
- DRUG Sorafenib
- DRUG Tivozanib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2016-05-24 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02627963
The ClinicalTrials.gov registry entry for NCT02627963 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AVEO Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT02627963 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02627963 about?
NCT02627963 is a clinical study titled "A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)". This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants...
What is the current status of trial NCT02627963?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2016-05-24. Estimated completion is 2021-06-21.
What interventions are being tested in trial NCT02627963?
The interventions under investigation include: Sorafenib (DRUG), Tivozanib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02627963?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
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