A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer

Purpose

This phase II trial studies how well olaparib and cediranib maleate work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome Measures:

1. Progression-free survival [ Time Frame: From the date of study enrollment to the investigator-determined date of progression, or death due to any cause, whichever occurs first, assessed up to 5 years ]

Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Will be tested using pairwise log-rank tests stratified by the factors.

Secondary Outcome Measures:

1. Overall survival [ Time Frame: From the date of study enrollment to the date of death regardless of the cause, assessed up to 5 years ]

Will be tested using pairwise log-rank tests stratified by the factors.

2. Objective tumor response [ Time Frame: Up to 5 years ]

Will be assessed by RECIST version 1.1. Will be tested using pairwise Cochran-Mantel-Haenszel tests stratified by the factors.

Age

18 to 65
65 and over

Gender

Female

Monetary compensation

No

Can be done from home

No

Keywords

Cediranib Maleate, Olaparib

Principal Investigator

Merry Jennifer Markham, MD

Sponsoring Group

Department of Medicine

Department

Department of Medicine

Contact Information

merry.markham@medicine.ufl.edu

352.265.0725


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