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Alessandro Santin MD
Date Terminated: 02/14/2020
To assess the activity of copanlisib (BAY 80-6946) in patients with persistent or recurrent endometrial carcinoma harboring PIK3CA hotspot mutations with the frequency of objective response.
Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified [NOS]).
All patients must have a somatic PIK3CA gene mutation is a representative primary or metastatic tumor sample confirmed by the Roche COBAS® PIK3CA Mutation Test at Q2 Solutions.
All patients must have measurable disease as defined by RECIST 1.1; patients must have at least one “target lesion” to be used to assess response as defined by RECIST 1.1.
Patients must have had a least one prior chemotherapeutic regimen for management of endometrial carcinoma; patients are allowed to receive, but not required to receive, up to a total of three lines of chemotherapy.
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