NRG-GY028

Open to Accrual

Return to Protocol Table

A Phase IB and Randomized Phase II trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Principal Investigator

Michaela Onstad Grinsfelder, MD, MPH

Status

Open to Accrual

Date Opened To Accrual

January 13 2023

Disease Site

Gynecologic [GY]

Uterine Corpus

Phase

I/II

Developmental Therapeutics

Primary Objective

Phase I: Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose.

Phase II: Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid adenocarcinoma of the endometrium.Compare the toxicity of the combination of ipatasertib with megestrol acetate to megestrol acetate alone.

Patient Population

Patients with grade 1 or 2 recurrent ormetastatic endometrioid endometrial cancer with measurable disease according toRECIST v 1.1. Patients may have received unlimited prior lines of therapy.

Target Accrual

Study Memos

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.

Support NRG Oncology.
Help Our Cause.

We are a leading protocol organizations within the National Clinical Trials Network and we seek to improve the lives of cancer patients by conducting practice-changing, multi-institutional clinical and translational research. Learn More

Donate Today

NRG Oncology Foundation, Inc, is a nonprofit, tax-exempt foundation. Donations to NRG Oncology help us conduct this important mission, and are tax-deductible to the extent permitted by law.