NRG-GY008: 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/Co-Principal Investigator

Alessandro Santin, M.D./Michal Birrer, M.D., M.P.H.

Primary Objectives

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

First stage:  15; Second stage: additional 10


Temporary Hold on Screening for Stage 1: April 13, 2017

Amendment 3; April 10, 2017

Amendments 1 and 2; January 9, 2017

Activated 09/16/2016; Sites will be notified when mutation screening and study drug are available for patient entry to begin.

Protocol Documents

The protocol and related documents are available at NRG-GY008 (Enter CTEP IAM credentials to access NRG Oncology Member Login)

Copyright 2017 by NRG Oncology