17 completed, 3 terminated, 1 withdrawn. 21 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 21 | Completed 17, Terminated 3, Withdrawn 1 |
| Phase 1 | 4 | Completed 4 |
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 |
| 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 |
| 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 |
| 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 |
| 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 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 |
| 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 |
| Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma Tivantinib, Diagnostic laboratory biomarker analysis, Questionnaire administration - Refractory Multiple Myeloma | Phase 2 | Completed | National Cancer Institute (NCI) | 16 | 2011-11-01 | 2019-08-28 |
| Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer ARQ 197 plus erlotinib, Pemetrexed, docetaxel or gemcitabine - Metastatic Non-Small Cell Lung Cancer | Phase 2 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 96 | 2011-07-01 | 2018-04-03 |
| An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols Tivantinib, Anti-Cancer Combination Therapy - Advanced Solid Tumors | Phase 1 / Phase 2 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 60 | 2010-08-31 | 2021-03-10 |
| Study of ARQ 197 Monotherapy ARQ 197 - Gastric Cancer | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 31 | 2010-06-01 | 2017-03-15 |
| ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors Tivantinib (ARQ 197) - Non-CNS Germ Cell Tumors (Seminomas and Nonseminomas) | Phase 2 | Terminated | Daiichi Sankyo | 27 | 2010-02-02 | 2021-04-06 |
| ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer Tivantinib, Placebo, Cetuximab - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Completed | Daiichi Sankyo | 131 | 2010-01-26 | 2021-04-08 |
| Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy ARQ 197, Placebo - Unresectable Hepatocellular Carcinoma | Phase 2 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 107 | 2009-09-01 | 2013-02-28 |
| A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) ARQ 197, Erlotinib, Placebo - Non Small Cell Lung Cancer | Phase 2 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 167 | 2008-09-01 | 2013-02-28 |
| A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma ARQ 197, gemcitabine - Pancreatic Neoplasms | Phase 2 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 43 | 2007-11-01 | 2013-02-25 |
| Phase 2 Study in Patients With MiT Tumors ARQ 197 - Renal Cell Carcinoma (RCC), Alveolar Soft Part Sarcoma (ASPS) | Phase 2 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 47 | 2007-10-01 | 2013-02-08 |
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Carcinoma, Non-Small-Cell Lung (4) · Carcinoma, Renal Cell (3) · Breast Neoplasms (2) · Mesothelioma, Malignant (2) · Stomach Neoplasms (2) · Amyloidosis (1) · Anemia (1) · Bone Diseases, Metabolic (1) · Carcinoma (1) · Carcinoma, Hepatocellular (1) · Carcinoma, Small Cell (1) · Colorectal Neoplasms (1) · Fractures, Spontaneous (1) · Hematologic Neoplasms (1) · Hypercalcemia (1)
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) (7) · National Cancer Institute (NCI) (6) · Armando Santoro, MD (2) · Daiichi Sankyo (2) · Kyowa Kirin Co., Ltd. (2) · Istituto Oncologico Veneto IRCCS (1) · SCRI Development Innovations, LLC (1)
United States (13) · Italy (5) · Germany (3) · Canada (2) · France (2) · Japan (2) · Poland (2) · Russia (2) · United Kingdom (2) · Belgium (1) · Latvia (1) · South Korea (1) · Ukraine (1)
Armando Santoro, MD (1) · Cezary Szczylik, PhD (1) · Emilia Filipczyk-Cisarz, MD (1) · Ewa Kilar, MD (1) · Giulia Pasello, MD (1) · Hedy Kindler (1) · J. Monk (1) · Janusz Pawlega, PhD (1) · Johanna C Bendell, M.D. (1) · Lorenza Rimassa, MD (1) · Piotr Koralewski, MD (1) · Piotr Sawrycki, MD (1) · Przemyslaw Twardowski (1)
PMID 22605650, PMID 23182627, PMID 26123926, PMID 27843623
N01CM00071 (3), P30CA014599 (2), 2014 (1), N01CM00038 (1), N01CM00039 (1), N01CM00070 (1), N01CM00099 (1), N01CM00100 (1), N01CM62207 (1), P30CA006516 (1), P30CA016058 (1), P30CA016672 (1), U01CA062461 (1), U01CA062490 (1), U01CA062491 (1)