Minireviews
Copyright ©The Author(s) 2015.
World J Gastroenterol. May 14, 2015; 21(18): 5445-5453
Published online May 14, 2015. doi: 10.3748/wjg.v21.i18.5445
Table 1 Overview of important clinical trials
First author, Journal (Year)Study designEnrollment periodDrugsPatientsNo. Pts
Santoro, BJC (2013)Phase I, open-label, single-arm study (full-text), NCT008025552009.3- 2010.11 completedTivantinibAdvanced HCC, Child-Pugh A cirrhosis, previously treated with sorafenib or other therapy21
Santoro, Lancet Oncol (2013)Phase II double-blind, placebo-controlled, RCT (full-text), NCT009887412009.10.8- 2011.8.25 completedTivantinib vs placeboAdvanced HCC with or without MET-high tumors, who had progressed on or were unable to tolerate first-line systemic therapy107
Verslype/Cohn, JCO (2012, May/Feb)Phase II randomized discontinuation trial (abstract), NCT00940225CompletedPR: Continued open-label cabozantinib; SD: Cabozantinib vs placebo; PD: DiscontinuedAdvanced HCC, ≤ 1 prior systemic regimen, Child-Pugh A41
Novartis PharmaceuticalsPhase II, open label, single-arm study (registration), NCT01737827OngoingINC280Advanced HCC which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy, c-MET pathway dysregulation56
Novartis PharmaceuticalsPhase II, double-blind, placebo-controlled RCT (registration), NCT01964235SuspendedINC280 vs placeboAdult patients with advanced HCC after progression or intolerance to sorafenib treatment, c-MET pathway dysregulation69
Merck KGaAPhase Ib/II, single-arm, trial (registration), NCT02115373OngoingMSC2156119JAdvanced HCC, MET+, Child-Pugh A, who have failed sorafenib treatment48
Qin, JCO (2014)Phase Ib/II RCT (abstract), NCT01988493OngoingPhase II: MSC2156119J vs sorafenibAsian patients, MET-positive, advanced HCC, Child-Pugh A158
O'Neil, JCO (2013)Phase Ib/II, open-label, study (abstract), NCT01271504OngoingPhase Ib: Golvatinib plus sorafenib; Phase II: Golvatinib plus sorafenib vs sorafenib aloneAdvanced HCC13
Yau, JCO (2012)Phase I/II trial (abstract), NCT00920192OngoingForetinibAdvanced HCC13
Santoro, JCO (2013)Phase III, double-blind, RCT (abstract), NCT01755767OngoingTivantinib vs placeboMET diagnostic-high inoperable HCC treated with one prior systemic therapy303
Abou-Alfa, JCO (2014)Phase III, double-blind, RCT (abstract), NCT01908426OngoingCabozantinib vs placeboAdvanced HCC who have received prior sorafenib760