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. 2021 Nov 2;12:731527. doi: 10.3389/fimmu.2021.731527

Table 1.

Trials of tivantinib in treating HCC registered in the - ClinicalTrials.gov.

Clinical Trials ID Study area Status Cancer type, Number of patients Age (years) Therapies (Tivantinib) Time Frame Responsible Party Outcomes Serious Adverse Events (%)
NCT00802555, Phase 1 Multi-center Completed Cirrhotic patients with HCC, 21 Over 18 360 mg, BID, Orally January 2009 to December 2011 Merck Sharp and Dohme No Results Posted No Results Posted
NCT00827177, Phase 1 Multi-center Completed HCC and other solid tumors, 87 Over 18 360 mg vs 240 mg, BID, Orally September 2009 to May 2013 Merck Sharp and Dohme No Results Posted No Results Posted
NCT01656265, Phase 1 Japan Completed Advanced HCC, 24 Over 20 Daily repeating dose of oral Tivantinib (lack of dose), BID, Orally July 2012 to March 2014 Kyowa Kirin No Results Posted No Results Posted
NCT01755767, Phase 3 Multi-center Completed MET-high HCC, 383 Over 18 120 mg vs 240 mg vs Placebo, BID, Orally December 27, 2012 to July 31, 2017 Merck Sharp and Dohme Median OS: 8.4 (6.8 to 10.0) for Tivantinib vs 9.1 (7.3 to 10.4) for Placebo;
Median PFS: 2.1 for Tivantinib and 2.0 for Placebo
Tivantinib 240 mg: 17/28 (60.71%);
Tivantinib 120 mg:
103/225 (45.78%)
NCT00988741, Phase 2 USA Completed Unresectable HCC, 107 Over 18 360 mg vs 240 mg vs Placebo, BID, Orally September 2009 to March 2012 Merck Sharp and Dohme No Results Posted No Results Posted
NCT02029157, Phase 3 Japan Completed MET-high HCC, 386 Over 20 NA January 2014 to August 2017 Kyowa Kirin No Results Posted No Results Posted
NCT01178411, Phase 1 NA Completed HCC and other solid tumors, 60 Over 13 360 mg, BID, Orally August 31, 2010 to January 14, 2019 Merck Sharp and Dohme NA 19/60 (31.67%)

NA, Not available; HCC, Hepatocellular carcinoma; HR, Hazard ratio; CI, Confidence interval; OS, Overall Survival; PFS, Progress Free Survival.