CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 149 enrolled
Drug / intervention
MSC2156119Jdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01014936
NCT01014936Phase 1Completed

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

EMD Serono·interventional·Posted Nov 17, 2009·Updated Aug 24, 2022

In Brief

A Phase 1 clinical trial evaluating MSC2156119J for Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available. Completed, enrolled 149 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2009
Enrollment StartNov 30, 2009
Primary CompletionOct 31, 2015
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.6 years ago

Interventions

MSC2156119Jdrug