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 |
|---|---|---|---|---|---|---|
| NCT01014936 ↗ | First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors | Completed | Merck KGaA | Phase 1 | 2009-11-30 | This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle) |
| NCT01014936 ↗ | First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors | Completed | Merck KGaA, Darmstadt, Germany | Phase 1 | 2009-11-30 | This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle) |
| NCT01014936 ↗ | First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors | Completed | EMD Serono | Phase 1 | 2009-11-30 | This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: - Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) - Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) - Regimen 3: MSC2156119J every day for three weeks (21-day cycle) |
| NCT01982955 ↗ | Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT) | Completed | Merck KGaA | Phase 1/Phase 2 | 2013-12-23 | This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm). |
| NCT01982955 ↗ | Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT) | Completed | Merck KGaA, Darmstadt, Germany | Phase 1/Phase 2 | 2013-12-23 | This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with gefitinib in partcipants with T790M negative, MET positive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation and having acquired resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy. This study has 2:1 randomization (Tepotinib/Gefitinib arm versus Chemotherapy arm). |
| NCT01988493 ↗ | Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma | Completed | Merck KGaA | Phase 1/Phase 2 | 2014-01-06 | This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer (BCLC) Stage C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and Child-Pugh class A liver function. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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