A Phase I Open-label, Non-randomized, Dose-escalation First-in-man Trial to Investigate the c-Met Kinase Inhibitor EMD 1204831 in Subjects With Advanced Solid Tumors
This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore the
safety, tolerability, pharmacokinetics, and clinical activity of an investigational drug,
EMD 1204831, in patients with advanced solid tumors who have not responded to previous
therapies or for whom no other therapies are available. Subjects will receive EMD 1204831
twice a day (BID) during each 21-day cycle until disease progression or unacceptable
toxicity.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) of EMD 1204831 in subjects with advanced solid tumors
After first cycle of treatment
No
Manfred Klevasath, MD
Study Director
Merck KGaA
United States: Food and Drug Administration
EMR200096-001
NCT01110083
April 2010
Name | Location |
---|---|
M.D. Anderson Cancer Center | Houston, Texas 77030 |