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Last Updated: August 7, 2020

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CLINICAL TRIALS PROFILE FOR TIVANTINIB

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Clinical Trials for Tivantinib

Trial ID Title Status Sponsor Phase Summary
NCT00777309 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) Completed ArQule Phase 2 This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.
NCT00988741 Trial of ARQ 197 in Patients With Unresectable Hepatocellular Carcinoma (HCC) Who Have Failed One Prior Systemic Therapy Completed ArQule Phase 2 This is a global randomized, placebo-controlled, double-blinded Phase 2 study designed to compare treatment of ARQ 197 versus placebo in patients with unresectable HCC who had radiographic disease progression after systemic first line therapy or were unable to tolerate the therapy.
NCT01055067 ARQ 197 for Subjects With Relapsed or Refractory Germ Cell Tumors Completed Daiichi Sankyo Inc. Phase 2 This is a multicenter, single-arm study for safety and efficacy.
NCT01075048 ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer Completed Daiichi Sankyo Inc. Phase 1/Phase 2 ARQ 197 or placebo in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer (CRC), in subjects with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2.
NCT01149720 Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors Completed ArQule Phase 1 This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.
NCT01149720 Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors Completed ICON Clinical Research Phase 1 This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Tivantinib

Condition Name

Condition Name for
Intervention Trials
Solid Tumors 3
Adult Solid Neoplasm 2
Malignant Pleural Mesothelioma 1
Type 2 Papillary Renal Cell Carcinoma 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Carcinoma 6
Lung Neoplasms 5
Carcinoma, Hepatocellular 3
Carcinoma, Non-Small-Cell Lung 3
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Clinical Trial Locations for Tivantinib

Trials by Country

Trials by Country for
Location Trials
United States 185
Italy 10
Canada 10
Brazil 9
Spain 6
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Trials by US State

Trials by US State for
Location Trials
California 14
Texas 13
Pennsylvania 10
Illinois 10
Florida 10
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Clinical Trial Progress for Tivantinib

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 12
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 15
Active, not recruiting 10
Terminated 1
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Clinical Trial Sponsors for Tivantinib

Sponsor Name

Sponsor Name for
Sponsor Trials
National Cancer Institute (NCI) 11
Daiichi Sankyo Inc. 9
ArQule 6
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 20
NIH 11
Other 5
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