BACKGROUND: The efficacy and safety of @entity16231 , a potent and selective vascular endothelial growth factor receptors 1-3 inhibitor, combined with best supportive care (BSC) was evaluated in a global, randomized, placebo-controlled phase II trial in @entity1 with locally advanced or metastatic @entity157 ( @entity157 ). @entity1 AND METHODS: @entity1 with @entity157 and @entity1 -Pugh Class A who progressed on or were intolerant to one prior antiangiogenic therapy were stratified by @entity5 invasion (presence/absence of extrahepatic spread and/or vascular invasion) and region (Asian/non-Asian) and randomized (2:1) to @entity16231 /BSC (starting dose 5 mg twice-daily) or placebo/BSC. The primary end point was @entity1349 ( @entity1349 ). RESULTS: The estimated hazard ratio for @entity1349 was 0.907 [95% confidence interval (CI) 0.646-1.274; one-sided stratified P = 0.287] for @entity16231 /BSC (n = 134) versus placebo/BSC (n = 68), with the median (95% CI) of 12.7 (10.2-14.9) versus 9.7 (5.9-11.8) months, respectively. Results of prespecified subgroup analyses in Asian versus non-Asian @entity1 or presence versus absence of @entity5 invasion were consistent with the overall population. Improvements favouring @entity16231 /BSC (P < 0.01) were observed in secondary efficacy end point analyses [progression-free survival (PFS), time @entity5 ( @entity5 ), and clinical benefit rate (CBR)], and were retained among Asian @entity1 in the prespecified subgroup analyses. Overall response rate did not differ significantly between treatments and @entity1 -reported outcomes favoured placebo/BSC. Most common all-causality adverse events with @entity16231 /BSC were @entity294 (54%), @entity101 (54%), and decreased appetite (47%). Baseline serum analyses identified potential new prognostic ( @entity650 , @entity4105 , @entity687 , @entity877 , migration inhibitory factor, and @entity1916 ) or predictive ( @entity4105 and stromal-derived factor-1) factors for survival. CONCLUSIONS: @entity16231 /BSC did not improve @entity1349 over placebo/BSC in the overall population or in stratification subgroups. However, @entity16231 /BSC resulted in significantly longer PFS and @entity5 and higher CBR, with acceptable @entity137 in @entity1 with advanced @entity157 . TRIAL REGISTRATION: ClinicalTrials.gov, NCT01210495.

Randomized phase II study of @entity16231 versus placebo plus best supportive care in second-line treatment of advanced XXXX .

@entity1 :: ('9606', 'Species') :: ['Child', 'patient', 'Patients', 'patients', 'PATIENTS'] @entity650 :: ('3569', 'Gene') :: ['interleukin-6'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity101 :: ('MESH:D006973', 'Disease') :: ['hypertension'] @entity16231 :: ('MESH:C503983', 'Chemical') :: ['axitinib', 'Axitinib'] @entity5 :: ('MESH:D009369', 'Disease') :: ['TTP', 'tumour', 'to tumour progression'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhoea'] @entity4105 :: ('6401', 'Gene') :: ['E-selectin'] @entity877 :: ('285', 'Gene') :: ['angiopoietin-2'] @entity1916 :: ('4233', 'Gene') :: ['c-MET'] @entity157 :: ('MESH:D006528', 'Disease') :: ['hepatocellular carcinoma', 'HCC'] @entity687 :: ('3576', 'Gene') :: ['interleukin-8'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity157 :: (MESH:D006528,Disease) :: ['hepatocellular carcinoma']
