INNO-206 in Patients With Small Cell Lung Cancer (SCLC)
The purpose of this study is to determine whether INNO-206 is effective in the treatment of small cell lung cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open-label Study of INNO-206 in Patients With Recurrent Extensive Small Cell Lung Cancer After First-line Platinum-based Therapy|
- To determine the objective overall response rate (OR; complete [CR] and partial [PR] responses).
- To determine the rates of stable disease and progressive disease.
- To determine time to progression.
- To determine progression-free survival.
- To determine overall survival.
- To evaluate the treatment-related toxicities in this patient population.
- To determine the pharmacokinetic profile of INNO-206 in a minimum of 12 patients.
|Study Start Date:||May 2008|
|Study Completion Date:||November 2008|
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.
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Montana|
|Billings, Montana, United States, 59107|
|United States, New York|
|New York Oncology Hematology, P.C.|
|Albany, New York, United States, 12206|
|United States, Ohio|
|Dayton Oncology and Hematology|
|Kettering, Ohio, United States, 45409|
|Signal Point Hematology/Oncology, Inc.|
|Middletown, Ohio, United States, 45042|
|United States, South Carolina|
|Cancer Centers of the Carolinas|
|Greenville, South Carolina, United States, 29605|
|United States, Texas|
|Mary Crowley Medical Research Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Michael Maitland, MD||University of Chicago|