CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 224 enrolled
Drug / intervention
Axitinib (AG-013736) +3 moredrug
Likely dose
Axitinib (AG-013736) 1 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.

Search/NCT01210495
NCT01210495Phase 2Completed
CompareCT.gov

A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY

Pfizer·interventional·Posted Sep 28, 2010·Updated Jan 9, 2019

In Brief

A Phase 2 clinical trial evaluating Axitinib (AG-013736), Best Supportive Care, and 1 other intervention for Hepatocellular Carcinoma. Completed, enrolled 224 participants across 77 sites in 13 countries.

Detailed Summary

The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesBelgium, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Slovakia, South Korea, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2010
Enrollment StartDec 6, 2010
Primary CompletionMar 3, 2014
Study CompletionDec 20, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.8 years ago

Interventions

Axitinib (AG-013736)drug

Axitinib \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID

Best Supportive Careother

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Placebodrug

Placebo \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID

Best Supportive Careother

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.