A Phase II Evaluation of Copanlisib BAY 80-6946 IND #130822, A Selective Inhibitor of PI3KCA, in patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations
Principal Investigator
Alessandro Santin, MD
Status
Terminated
Date Opened To Accrual
September 16 2016
Date Closed to Accrual
August 07 2017
Date of Study Termination
February 14 2020
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
II
Developmental Therapeutics
No
Primary Objective
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.
Patient Population
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.
Target Accrual
25
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.