This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
assess the efficacy of BEZ235 as measured by Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: every 8 weeks
evaluate additional efficacy parameters (e.g. Disease Control Rate, Progression-Free Survival)
Time frame: every 8 weeks
evaluate safety of BEZ235. Safety assessments will include vital signs, laboratory tests, and frequency of adverse events (non-serious and serious).
Time frame: Treatment start until 30 days after the last dose
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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
City of Hope Medical center
Duarte, California, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Morriswon Memorial Hospital
Morristown, New Jersey, United States
Carolinas Healthcare Systems
Charlotte, North Carolina, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
GHS
Danville, Pennsylvania, United States
...and 49 more locations