NRG-GY008

Terminated

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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 D. Santin

Status

Terminated

Open to Accrual

September 16, 2016

Temporarily Closed to Accrual

August 7, 2017

Closed to Accrual

August 7, 2017

Closed to Accrual & Treatment

December 31, 2018

Complete

February 14, 2020

Terminated

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

28

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.