Table 1.
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.