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, MD
Status
Closed to Accrual
Date Opened To Accrual
August 27 2018
Date 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
168
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.