25 completed. 25 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 25 |
| Phase 2 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 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 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 |
| 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 |
| 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 |
| Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects tivantinib, omeprazole, s-warfarin - Solid Tumors | Phase 1 | Completed | Daiichi Sankyo | 28 | 2011-12-01 | 2019-02-12 |
| A Study of ARQ 197 in Combination With Erlotinib ARQ 197 and Erlotinib - Advanced/Recurrent Non-small-cell Lung Cancer | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 9 | 2010-12-01 | 2017-03-15 |
| 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 |
| Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors Tivantinib (ARQ 197) Capsule, Tivantinib (ARQ 197) Tablet, Tivantinib (ARQ 197) Capsule D, oral - Solid Tumors | Phase 1 | Completed | Daiichi Sankyo | 24 | 2010-07-01 | 2019-02-12 |
| A Study of ARQ 197 in Combination With Erlotinib ARQ 197 and Erlotinib - Non-small-cell Lung Cancer | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 16 | 2010-02-01 | 2017-03-15 |
| 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 |
| Dose Escalation Study of ARQ 197 in Combination With Sorafenib in Adult Patients With Advanced Solid Tumors Treatment with ARQ 197 in combination with sorafenib - Advanced Solid Tumors | Phase 1 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 87 | 2009-09-01 | 2014-01-24 |
| Dose Escalation Study of ARQ 197 in Combination With Gemcitabine in Adult Patients With Advanced Solid Tumors Treatment with ARQ 197 in combination with gemcitabine - Advanced Solid Tumors | Phase 1 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 74 | 2009-03-01 | 2012-07-23 |
| Safety Study of ARQ 197 in Cirrhotic Patients With Hepatocellular Carcinoma (HCC) ARQ 197 - Cirrhosis, Hepatocellular Carcinoma | Phase 1 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 21 | 2009-01-01 | 2012-07-12 |
| Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers ARQ 197 - Healthy | Phase 1 | Completed | ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) | 24 | 2008-04-01 | 2008-06-19 |
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Neoplasms (9) · Carcinoma, Non-Small-Cell Lung (4) · Carcinoma, Hepatocellular (3) · Breast Neoplasms (2) · Carcinoma, Renal Cell (2) · Melanoma (2) · Colorectal Neoplasms (1) · Fibrosis (1) · Mesothelioma, Malignant (1) · Neoplasm Metastasis (1) · Ovarian Neoplasms (1) · Sarcoma (1)
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) (9) · Daiichi Sankyo (5) · National Cancer Institute (NCI) (5) · Kyowa Kirin Co., Ltd. (4) · Armando Santoro, MD (1) · SCRI Development Innovations, LLC (1)
United States (18) · Italy (4) · Japan (3) · Canada (1) · France (1) · Germany (1) · Russia (1) · Spain (1) · United Kingdom (1)
Hamim Zahir, BPharm, PhD (2) · Alice P Chen, M.D. (1) · Armando Santoro, MD (1) · Barbara Gitlitz (1) · James Geller (1) · Johann DeBono, MBChB, FRCP (1) · Johanna C Bendell, M.D. (1) · Kari Wisinski (1) · Lee Rosen, MD (1) · Leonard Appleman (1) · Masaya Tachibana, PhD (1) · Richard G Just, MD (1) · Ronald Kimberlin, MD (1)
PMID 21383285, PMID 22605616, PMID 24737778, PMID 34164713
P30CA014520 (1), P30CA033572 (1), P30CA047904 (1), U01CA062491 (1), U01CA062505 (1), U01CA097452 (1), U01CA099168 (1), UM1CA186690 (1), UM1CA186717 (1)