Drugs / Tivantinib
Trials 44
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 119 trials | ||||||
| Phase 1 | NCT02150733 | Apr 2014 → Dec 2015 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01749384 | Dec 2012 → May 2016 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01725191 | Oct 2012 → May 2015 | childhood neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01654965 | Jul 2012 → Mar 2018 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01699061 | Jul 2012 → Jan 2013 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01656265 | Jul 2012 → Mar 2014 | hepatocellular carcinoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01625156 | May 2012 → Sep 2015 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01468922 | Jan 2012 → Sep 2014 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01517399 | Dec 2011 → Aug 2013 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01251796 | Dec 2010 → Nov 2012 | non-small cell lung carcinoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01149720 | Jul 2010 → Mar 2011 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01069757 | Feb 2010 → Sep 2011 | non-small cell lung carcinoma | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00827177 | Sep 2009 → Sep 2012 | cancer | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00874042 | Mar 2009 → Feb 2011 | cancer | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00802555 | Jan 2009 → Dec 2011 | cirrhosis of liver, hepatocellular carcinoma | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00651638 | Mar → May 2008 | — | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00612703 | Feb 2008 → Sep 2010 | cancer | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00612209 | Apr 2007 → Jan 2010 | — | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00302172 | Jan 2006 → ? | cancer | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1/24 trials · 1 missed | ||||||
| Phase 1/2 | NCT02049060 | Jan 2013 → May 2016 | malignant pleural mesothelioma, non-small cell lung carcinoma | Armando Santoro, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT01611857 | Jul 2012 → Jul 2015 | gastroesophageal cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT01178411 | Aug 2010 → Jan 2019 | cancer | ArQule, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01075048 | Jan 2010 → Oct 2012 | colorectal cancer | Daiichi Sankyo | Completed | Missed primary |
| Phase 217 trials · 2 met primary · 4 missed | ||||||
| Phase 2 | NCT02608411 | Feb 2016 → Feb 2017 | small cell carcinoma | Veneto Institute of Oncology IRCCS | Terminated | No outcome recorded |
| Phase 2 | NCT01892527 | Mar 2013 → May 2016 | colorectal cancer | Armando Santoro, MD | Completed | No outcome recorded |
| Phase 2 | NCT01861301 | Jan 2013 → Mar 2015 | malignant epithelioid mesothelioma, malignant pleural mesothelioma, sarcomatoid mesothelioma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT01688973 | Aug 2012 → Apr 2017 | papillary renal cell carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01696955 | Aug 2012 → May 2017 | head and neck squamous cell carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT01580735 | May 2012 → Apr 2015 | non-small cell lung carcinoma | Kyowa Kirin, Inc. | Completed | Missed primary |
| Phase 2 | NCT01575522 | Mar 2012 → Jul 2013 | female breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT01519414 | Jan 2012 → Aug 2015 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT01447914 | Nov 2011 → Mar 2014 | refractory plasma cell neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01395758 | Jul 2011 → Aug 2016 | non-small cell lung carcinoma | ArQule, Inc. | Completed | Missed primary |
| Phase 2 | NCT01152645 | Jun 2010 → Aug 2011 | gastric cancer | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01055067 | Feb 2010 → Nov 2011 | germ cell tumor | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 2 | NCT00988741 | Sep 2009 → Oct 2011 | hepatocellular carcinoma | ArQule, Inc. | Completed | Met primary |
| Phase 2 | NCT00777309 | Sep 2008 → May 2011 | non-small cell lung carcinoma | ArQule, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00558207 | Nov 2007 → Apr 2008 | malignant exocrine pancreas neoplasm | ArQule, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00557609 | Oct 2007 → Dec 2010 | alveolar soft part sarcoma, clear cell sarcoma, renal cell carcinoma | ArQule, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01070290 | — | gastric cancer | ArQule, Inc. | Withdrawn | No outcome recorded |
| Phase 34 trials · 4 missed | ||||||
| Phase 3 | NCT02029157 | Jan 2014 → Aug 2017 | liver cancer | Kyowa Kirin, Inc. | Completed | Missed primary |
| Phase 3 | NCT01755767 | Dec 2012 → Mar 2017 | hepatocellular carcinoma | Daiichi Sankyo | Completed | Missed primary |
| Phase 3 | NCT01377376 | Jul 2011 → Nov 2015 | non-small cell lung carcinoma | Kyowa Kirin, Inc. | Terminated | Missed primary |
| Phase 3 | NCT01244191 | Jan 2011 → Dec 2012 | non-small cell lung carcinoma | Daiichi Sankyo | Terminated | Missed primary Stop: Business |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00609921 Comparator | Jan 2008 → Sep 2011 | cancer | Kyowa Kirin, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2017-03-27 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Top-Line Results of Japanese Phase 3 Clinical Study of ARQ197 (tivantinib) in Hepatocellular Carcinoma kyowakirin.com ↗
The primary endpoint is progression-free survival (PFS), and the top-line results did not show a significant difference in PFS, between the tivantinib group and the placebo group. |
| 2017-02-20 | Daiichi Sankyo | Results Daiichi Sankyo and ArQule Announce the Completion of the METIV-HCC Phase 3 Study of Tivantinib in Second-Line Treatment of MET-Overexpressing Hepatocellular Carcinoma daiichisankyo.com ↗
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo today announced that the METIV-HCC phase 3 study of tivantinib in hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival. |
| 2013-01-15 | Daiichi Sankyo | Results DAIICHI SANKYO AND ARQULE ANNOUNCE TOP-LINE RESULTS OF PHASE 2 TRIAL WITH TIVANTINIB IN COLORECTAL CANCER daiichisankyo.com ↗
DAIICHI SANKYO AND ARQULE ANNOUNCE TOP-LINE RESULTS OF PHASE 2 TRIAL WITH TIVANTINIB IN COLORECTAL CANCER |
| 2012-10-02 | Daiichi Sankyo | Results ARQULE AND DAIICHI SANKYO ANNOUNCE DISCONTINUATION OF PHASE 3 MARQUEE CLINICAL TRIAL IN NON-SMALL CELL LUNG CANCER daiichisankyo.com ↗
Although the interim analysis showed a statistically significant improvement in progression-free survival (PFS) in the intent-to-treat (ITT) population, this benefit did not carry over to overall survival. |
| 2012-08-30 | Kyowa Kirin, Inc. | Results Kyowa Hakko Kirin Announces Temporary Suspension of Patient Enrollment for Phase 3 Clinical Study of ARQ 197 (Tivantinib) in Combination with Erlotinib in Non-Small-Cell Lung Cancer Patients kyowakirin.com ↗
Patient enrollment has been suspended based on the higher frequency of interstitial lung disease cases in the study as one of drug-related adverse reactions. |
| 2012-06-04 | Daiichi Sankyo | Results POSITIVE PHASE 2 STUDY RESULTS FOR TIVANTINIB IN PREVIOUSLY TREATED HEPATOCELLULAR CARCINOMA TO BE PRESENTED AT ASCO daiichisankyo.com ↗
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo Co., Ltd. (TSE: 4568) today announced final results from a randomized, placebo-controlled, double-blind, phase 2 clinical trial with the selective MET inhibitor tivantinib as a single-agent, investigational, second-line treatment in hepatocellular carcinoma (HCC). |
| 2010-06-07 | Daiichi Sankyo | Results ARQULE AND DAIICHI SANKYO PRESENT FINAL PHASE 2 RESULTS FOR ARQ 197 C-MET INHIBITOR IN NON-SMALL CELL LUNG CANCER AT ASCO daiichisankyo.com ↗
ARQ 197 in combination with erlotinib showed promising overall survival, consistent with efficacy signal seen in progression-free survival |
All press releases naming this drug 15 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 52 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tivantinib | “A randomized, double-blind, placebo-controlled, phase III trial of erlotinib with or without a c-Met inhibitor tivantinib (ARQ 197) in Asian patients with previously treated...” PMID 26153496 ↗ Jul 201528“Tivantinib (ARQ 197), a selective inhibitor of MET, in patients with microphthalmia transcription factor-associated tumors: results of a multicenter phase 2 trial.” PMID 22605650 ↗ May 2012 “Tivantinib (ARQ 197) is a selective, oral, non-ATP-competitive, small-molecule inhibitor of the MET receptor tyrosine kinase.” PMID 22605616 ↗ May 2012 “Tivantinib (ARQ 197) is an orally available, non-adenosine triphosphate competitive, selective c-MET inhibitor.” PMID 24737778 ↗ Apr 2014 “c-Met selective inhibitor, tivantinib (ARQ 197), in combination with erlotinib” PMID 27843623 ↗ Jul 2016 “c-Met inhibitor tivantinib” PMID 32716114 ↗ Aug 2020 “Tivantinib” NCT01149720 ↗ |
| Known as | ARQ 197 | “BACKGROUND: Tivantinib (ARQ 197), a selective, oral MET inhibitor, improved overall survival and progression-free survival compared with placebo in a randomised phase 2 study...” PMID 29625879 ↗ Apr 201830“Eligible subjects will be treated with tivantinib (ARQ 197) at a dose of 360 mg twice daily (a total daily dose of 720 mg) orally in a continuous manner and cetuximab (Erbitux)...” NCT01892527 ↗ “patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 (tivantinib) or ARQ 197 combined with erlotinib” NCT01688973 ↗ “Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride” NCT01251796 ↗ “An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols” NCT01178411 ↗ “Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib” NCT01377376 ↗ “Single agent activity for ARQ 197 (tivantinib) in patients who have failed cetuximab.” NCT01696955 ↗ “Tivantinib (ARQ 197) Capsule” NCT01149720 ↗ “Drug: Tivantinib (ARQ 197)” NCT01055067 ↗ |
| Action | Inhibit | “This study assessed the activity of tivantinib (ARQ 197), a selective MET inhibitor, in patients with MiT-associated tumors.” PMID 22605650 ↗ May 2012 |
| Modality | Small molecule | “ARQ 197 is a novel small molecule drug designed to block the activity of c-Met” NCT00557609 ↗ |
| Route | Oral | “ARQ 197 given orally” NCT00302172 ↗ |
| Target | MET | “ARQ 197 is an oral, selective, non-adenosine triphosphate competitive c-MET inhibitor.” PMID 21383285 ↗ Mar 2011 |