Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response
Objective tumor response (OR) is defined as best response rating of complete response (CR or unconfirmed CR) or partial response (PR) according to the criteria defined in the Report of an International Workshop to Standardize Response Criteria for NHL. In patients with Chronic lymphocytic leukemia (CLL), OR is defined as best response rating of complete response (CR) or partial response (PR) according to the guidelines for the diagnosis and treatment of chronic lymphocytic leukemia of the International Workshop on Chronic Lymphocytic Leukemia.
Up to 10 months
No
Bayer Study Director
Study Director
Bayer
Belgium: Federal Agency for Medicinal Products and Health Products
16349
NCT01660451
November 2012
April 2017
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Great Falls, Montana 59405 | |
Birmingham, Alabama 35294 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Flint, Michigan 48532 | |
Kansas City, Kansas 66160 | |
Scarborough, Maine 04074 | |
Hackensack, New Jersey 07601 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Indianapolis, Indiana | |
Charleston, South Carolina |