A Phase II, Open-label Study of INNO-206 in Patients With Recurrent Extensive Small Cell Lung Cancer After First-line Platinum-based Therapy
This is a phase II, open-label, prospective, multicenter, single-arm study of INNO 206 in
adult patients with recurrent extensive small cell lung cancer sensitive to first-line
platinum-based therapy. The primary objective of the study is to determine the objective
overall response rate. Secondary objectives include evaluating the treatment-related
toxicities in this patient population and determining the pharmacokinetic (PK) profile of
INNO-206 in a minimum of 12 patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
Michael Maitland, MD
Principal Investigator
University of Chicago
United States: Food and Drug Administration
INNO-206-P2
NCT00472771
May 2008
November 2008
Name | Location |
---|---|
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
University of Chicago | Chicago, Illinois 60637 |
Dayton Oncology and Hematology | Kettering, Ohio |
Billings Clinic | Billings, Montana 59107-7000 |
Signal Point Hematology/Oncology, Inc. | Middletown, Ohio 45042 |