34
Participants
Start Date
March 23, 2016
Primary Completion Date
July 30, 2021
Study Completion Date
July 30, 2021
LCL161
Topotecan
Topotecan will also be administered orally. Patients in DL 1 will receive topotecan at 1.8 mg/m2 per day for the first 5 days of each 21-day cycle. Patients in DL 2 will receive topotecan at 2.3 mg/m2 per day for the first 5 days of each 21-day cycle. The maximum dose for topotecan will not exceed 2.3 mg/m2 per day in this study.
Pegylated GCSF (PEG-GCSF)
Pegylated GCSF (PEG-GCSF) (e.g. pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting.
Florida Cancer Specialists-Sarasota, Sarasota
Tennessee Oncology PLLC, Nashville
Oklahoma University Health Science Center/Stephenson Cancer Center, Oklahoma City
Collaborators (1)
Novartis Pharmaceuticals
INDUSTRY
SCRI Development Innovations, LLC
OTHER