40 completed, 5 terminated, 1 withdrawn. 25 Phase 1, 21 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 25 |
| Phase 2 | 21 | Completed 17, Terminated 3, Withdrawn 1 |
| Phase 3 | 4 | Completed 2, Terminated 2 |
Follow ARQ 197: new trials by email Literature Review of ARQ 197 trials Research Report on ARQ 197
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| TIvantinib as Maintenance Treatment in Extended Small-cell Lung Cancer (TIMES) ARQ197 - Carcinoma, Small Cell | Phase 2 | Terminated | Istituto Oncologico Veneto IRCCS | 5 | 2016-02-19 | 2023-10-13 |
| Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment Tivantinib - Hepatic Impairment, Solid Tumor | Phase 1 | Completed | Daiichi Sankyo | 29 | 2014-04-01 | 2019-02-12 |
| A Randomized Double-blind, Placebo-controlled Japanese Phase III Trial of ARQ 197 in Hepatocellular Carcinoma (HCC) ARQ197, Placebo - Liver Cancer | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 386 | 2014-01-01 | 2017-10-09 |
| Study of Tivantinib (ARQ 197) Plus Cetuximab in EGFR Inhibitor-Resistant MET High Subjects Tivantinib (ARQ197) - Colorectal Cancer Metastatic, C-met Overexpression | Phase 2 | Completed | Armando Santoro, MD | 43 | 2013-03-01 | 2022-09-09 |
| Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma Laboratory Biomarker Analysis, Tivantinib - Epithelioid Mesothelioma, Recurrent Malignant Mesothelioma | Phase 2 | Terminated | National Cancer Institute (NCI) | 18 | 2013-01-01 | 2016-10-24 |
| Study of the Combination of Tivantinib Plus Pemetrexed and Carboplatin Tivantinib - Malignant Pleural Mesothelioma, Nonsquamous Nonsmall Cell Neoplasm of Lung | Phase 1 / Phase 2 | Completed | Armando Santoro, MD | 31 | 2013-01-01 | 2021-01-22 |
| Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy Tivantinib, Placebo - Hepatocellular Carcinoma | Phase 3 | Completed | Daiichi Sankyo | 383 | 2012-12-27 | 2021-04-06 |
| Tivantinib and Bevacizumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study - Solid Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 12 | 2012-12-06 | 2017-10-12 |
| Tivantinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors Laboratory Biomarker Analysis, Pharmacological Study, Tivantinib - Childhood Solid Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 36 | 2012-10-01 | 2015-07-02 |
| Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery Erlotinib Hydrochloride, Laboratory Biomarker Analysis, Tivantinib - Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer | Phase 2 | Completed | National Cancer Institute (NCI) | 55 | 2012-08-20 | 2019-01-03 |
| Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Cannot Be Removed by Surgery Cetuximab, Laboratory Biomarker Analysis, Tivantinib - Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma | Phase 2 | Completed | National Cancer Institute (NCI) | 81 | 2012-08-20 | 2018-12-19 |
| Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors Laboratory Biomarker Analysis, Pegfilgrastim, Pharmacological Study - Adult Solid Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 17 | 2012-07-24 | 2018-04-03 |
| Effect of Tivantinib on the QTC Interval in Cancer Subjects Tivantinib, Placebo - Solid Tumors | Phase 1 | Completed | Daiichi Sankyo | 38 | 2012-07-01 | 2019-02-12 |
| Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach Tivantinib, FOLFOX - Malignant Solid Tumour, Gastroesophageal Cancer | Phase 1 / Phase 2 | Completed | SCRI Development Innovations, LLC | 49 | 2012-07-01 | 2016-11-23 |
| Study of ARQ 197 in Hepatocellular Carcinoma (HCC) ARQ 197 - Advanced Hepatocellular Carcinoma | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 24 | 2012-07-01 | 2017-03-03 |
| ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer ARQ 197 - Non-small-cell Lung Cancer | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 40 | 2012-05-01 | 2015-08-18 |
| Tivantinib and Temsirolimus in Treating Patients With Solid Tumors That is Metastatic or Cannot be Removed by Surgery Laboratory Biomarker Analysis, Pharmacological Study, Temsirolimus - Adult Solid Neoplasm | Phase 1 | Completed | National Cancer Institute (NCI) | 11 | 2012-05-01 | 2015-10-20 |
| Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer Laboratory Biomarker Analysis, Tivantinib - Estrogen Receptor Negative, HER2/Neu Negative | Phase 2 | Completed | National Cancer Institute (NCI) | 22 | 2012-03-01 | 2016-03-21 |
| Pazopanib and ARQ 197 for Advanced Solid Tumors Pazopanib, ARQ 197 - Solid Tumor | Phase 1 | Completed | National Cancer Institute (NCI) | 32 | 2012-01-23 | 2022-07-01 |
| Tivantinib in Treating Patients With Metastatic Prostate Cancer Laboratory Biomarker Analysis, Placebo, Tivantinib - Hormone-Resistant Prostate Cancer, Prostate Adenocarcinoma | Phase 2 | Completed | National Cancer Institute (NCI) | 78 | 2012-01-11 | 2018-09-12 |
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Carcinoma, Non-Small-Cell Lung (9) · Neoplasms (9) · Carcinoma, Hepatocellular (4) · Carcinoma, Renal Cell (4) · Breast Neoplasms (3) · Carcinoma (2) · Melanoma (2) · Mesothelioma, Malignant (2) · Stomach Neoplasms (2) · Amyloidosis (1) · Anemia (1) · Bone Diseases, Metabolic (1) · Carcinoma, Small Cell (1) · Colorectal Neoplasms (1) · Fibrosis (1)
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) (15) · National Cancer Institute (NCI) (11) · Daiichi Sankyo (8) · Kyowa Kirin Co., Ltd. (8) · Armando Santoro, MD (2) · Istituto Oncologico Veneto IRCCS (1) · SCRI Development Innovations, LLC (1)
United States (31) · Italy (9) · Japan (7) · Canada (5) · Germany (5) · France (4) · United Kingdom (4) · Belgium (3) · Poland (3) · Russia (3) · Spain (3) · Argentina (2) · Australia (2) · Austria (2) · Brazil (2)
Hamim Zahir, BPharm, PhD (2) · Alice P Chen, M.D. (1) · Armando Santoro, MD (1) · Barbara Gitlitz (1) · Cezary Szczylik, PhD (1) · Emilia Filipczyk-Cisarz, MD (1) · Ewa Kilar, MD (1) · Giulia Pasello, MD (1) · Hedy Kindler (1) · J. Monk (1) · James Geller (1) · Janusz Pawlega, PhD (1) · Johann DeBono, MBChB, FRCP (1)
PMID 21383285, PMID 22440336, PMID 22605616, PMID 22605650, PMID 23182627, PMID 24737778, PMID 26123926, PMID 26153496, PMID 26169611, PMID 27843623, PMID 29625879, PMID 32716114, PMID 34164713
N01CM00071 (3), P30CA014599 (2), U01CA062491 (2), 2014 (1), N01CM00038 (1), N01CM00039 (1), N01CM00070 (1), N01CM00099 (1), N01CM00100 (1), N01CM62207 (1), P30CA006516 (1), P30CA014520 (1), P30CA016058 (1), P30CA016672 (1), P30CA033572 (1)