NRG-GY012

Closed to Accrual

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A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer.: A Platform Trial for Women with Recurrent or Persistent Endometrial Cancer

Principal Investigator

Helen Mackay

Status

Closed to Accrual

Open to Accrual

September 4, 2018

Temporarily Closed to Accrual

February 4, 2019

Open to Accrual

April 8, 2019

Closed to Accrual

June 17, 2019

Temporarily Closed to Accrual

June 17, 2019

Open to Accrual

August 16, 2021

Temporarily Closed to Accrual

February 22, 2022

Open to Accrual

May 23, 2022

Closed to Accrual

June 28, 2023


Disease Site

Gynecologic [GY] Uterine Corpus

Phase

II

Developmental Therapeutics

No

Primary Objective

To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.
To compare the efficacy of the combination of olaparib and AZD5363 (capivasertib), and the combination of olaparib and durvalumab (MEDI4736), and the combination of cediranib and durvalumab (MEDI4736) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer. 

Patient Population

Patients with recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments. Histologic confirmation of the original primary tumor is required. 

Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.). NOTE: Clear cell and carcinosarcoma histology is excluded.

Target Accrual

120

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

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