Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
60
Medical College of GeorgiaDept of OBGYN
Augusta, Georgia, United States
University of MinnesotaObstetrics & Gynecology, MMC
Minneapolis, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
Phase I-To determine the MTD and evaluate the safety profile of oral lenalidomide and topotecan
Phase II-To explore the anti-tumor activity based on objective response rate (CR + PR) of the combination of oral lenalidomide and topotecan
Phase I-To explore the anti-tumor activity based on response of the combination of lenalidomide and topotecan.
Phase II-To explore the safety profile of the combination of lenalidomide and topotecan
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