This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive giredestrant 30 milligrams (mg) taken orally (PO) once a day (QD) on Days 1 to 28 of each 28-day cycle for 6 cycles. After completion of 6 cycles, the participant and investigator can choose to continue study treatment for an additional 18 cycles or discontinue study treatment and receive investigator-determined care.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Minnesota Oncology Minneapolis
Minneapolis, Minnesota, United States
Percentage of Participants Who Have Regression at 6 Months
The percentage of participants who have regression is defined as participants who have a decrease in the proportion of cancer in their endometrial biopsy or the proportion of cancer is not increased, but there is an increase in non-cancer/non-atypical hyperplasia at the 6-month assessment compared with baseline.
Time frame: Baseline, 6 Months
Number of Participants with at Least One Adverse Event, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
Time frame: From Baseline until 30 days after the final dose of study drug (up to 1 year, 6 months)
Percentage of Participants Who Have Complete Regression at 6 Months
The percentage of participants who have complete regression is defined as participants having an assessment of 100% of non-cancer/non-atypical hyperplasia at the Month 6 assessment.
Time frame: Baseline, 6 Months
Median Duration of Regression
Time frame: From first regression to first relapse (up to 1 year, 6 months)
Median Time to First Regression
Time frame: From first study treatment to first regression (up to 1 year, 6 months)
Median Time to Relapse or Loss of Clinical Benefit
Time frame: From first study treatment to relapse or loss of clinical benefit, whichever occurs first (up to 1 year, 6 months)
Plasma Concentration of Giredestrant at Specified Timepoints
Time frame: Predose on Day 1 of Cycles 1, 2, 3, 4, and 6; 3-4 hours Postdose on Day 1 of Cycles 1 and 2 (each cycle is 28 days)
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Englewood Health/Hematology Oncology Practice of Englewood (HOPE)
Englewood, New Jersey, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, Emilia-Romagna, Italy
...and 2 more locations