At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 492 enrolled
Drug / intervention
Axitinib (AG-013736) +1 moredrug
Likely dose
Axitinib (AG-013736) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
In Brief
A Phase 3 clinical trial evaluating Axitinib (AG-013736) and Sorafenib for Kidney Neoplasms. Completed, enrolled 492 participants across 125 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Neoplasms
CountriesBosnia and Herzegovina, Bulgaria, Chile, China, India, Malaysia, Mexico, Philippines, Romania, Russia, South Africa, Taiwan, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartAug 2009
Primary CompletionJul 2012
Study CompletionApr 2021
TodayJul 2026
First PostedJun 15, 2009
Enrollment StartAug 25, 2009
Primary CompletionJul 27, 2012
Study CompletionApr 29, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.0 years ago
Interventions
Axitinib (AG-013736)drug
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
Sorafenibdrug
sorafenib will be given at a dose of 400 mg BID continuous dosing