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Last Updated: May 10, 2021

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CLINICAL TRIALS PROFILE FOR TEPOTINIB HYDROCHLORIDE

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All Clinical Trials for Tepotinib Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02864992 Tepotinib Phase II Study in Lung Adenocarcinoma Harbouring MET Exon 14 (METex14) Skipping Alterations Recruiting Merck KGaA Phase 2 2016-09-01 This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer that carries a specific genetic alteration (MET exon 14 skipping alterations) and that did not respond to standard of care treatment such as chemotherapy (platinum doublet containing regimen). This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug
NCT02864992 Tepotinib Phase II Study in Lung Adenocarcinoma Harbouring MET Exon 14 (METex14) Skipping Alterations Recruiting EMD Serono Research & Development Institute, Inc. Phase 2 2016-09-01 This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer that carries a specific genetic alteration (MET exon 14 skipping alterations) and that did not respond to standard of care treatment such as chemotherapy (platinum doublet containing regimen). This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug
NCT03021642 Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers Completed Merck KGaA, Darmstadt, Germany Phase 1 2016-01-31 This is a Phase I, open label, randomized, crossover trial to investigate the relative bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference, test. The reference treatment refers to the current Phase II film-coated tablet (5 * 100 milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III film-coated tablet (1 * 500 mg film-coated tepotinib tablet).
NCT03492437 Effect of Tepotinib on the Pharmacokinetics (PK) of the P-glycoprotein (P-gp) Substrate Dabigatran Etexilate Completed Merck KGaA Phase 1 2018-05-17 This study will investigate the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.
NCT03531762 Effect of a Proton Pump Inhibitor on the Pharmacokinetics (PK) of Tepotinib Completed Merck KGaA Phase 1 2018-05-14 This study will investigate in healthy subjects (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose PK of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study will assess the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.
NCT03546608 Tepotinib Hepatic Impairment Trial Recruiting Merck KGaA Phase 1 2018-06-13 The study will investigate the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
NCT03546608 Tepotinib Hepatic Impairment Trial Recruiting EMD Serono Research & Development Institute, Inc. Phase 1 2018-06-13 The study will investigate the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tepotinib Hydrochloride

Condition Name

Condition Name for Tepotinib Hydrochloride
Intervention Trials
Healthy 6
Hepatic Impairment 1
Solid Tumor 1
Colorectal Neoplasms 1
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Condition MeSH

Condition MeSH for Tepotinib Hydrochloride
Intervention Trials
Carcinoma, Non-Small-Cell Lung 2
Lung Neoplasms 2
Liver Diseases 1
Adenocarcinoma 1
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Clinical Trial Locations for Tepotinib Hydrochloride

Trials by Country

Trials by Country for Tepotinib Hydrochloride
Location Trials
United States 15
Germany 9
France 9
Russian Federation 7
United Kingdom 4
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Trials by US State

Trials by US State for Tepotinib Hydrochloride
Location Trials
Massachusetts 2
Georgia 2
Florida 2
California 2
Washington 1
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Clinical Trial Progress for Tepotinib Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Tepotinib Hydrochloride
Clinical Trial Phase Trials
Phase 2 4
Phase 1/Phase 2 1
Phase 1 7
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Clinical Trial Status

Clinical Trial Status for Tepotinib Hydrochloride
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 4
Completed 3
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Clinical Trial Sponsors for Tepotinib Hydrochloride

Sponsor Name

Sponsor Name for Tepotinib Hydrochloride
Sponsor Trials
Merck KGaA 6
EMD Serono Research & Development Institute, Inc. 5
Merck KGaA, Darmstadt, Germany 4
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Sponsor Type

Sponsor Type for Tepotinib Hydrochloride
Sponsor Trials
Industry 17
Other 1
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