NCT01014936

First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors

A Phase I Open-label, Non-randomized, Dose-escalation First-in-man Trial to Investigate the c-Met Kinase Inhibitor MSC2156119J Under Three Different Regimens in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available

Interventions

Type	Name	Description
DRUG	MSC2156119J

Timeline

• Start date: 2009-11-30
• Primary completion: 2015-10-31
• Completion: 2015-10-31
• First posted: 2009-11-17
• Last updated: 2022-08-24
• Results posted: 2017-04-17

Locations

1 site across 1 country: United States