A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Hoffmann-La Roche
Study ID
NCT05634499
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Giredestrant — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 27, 2023
Status verified
Apr 2026
Primary completion
Aug 28, 2026
Completion
Aug 28, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Giredestrant

Primary Outcome Measure

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) ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
Mount Sinai Medical CenterMiami BeachFlorida33140-
Minnesota Oncology MinneapolisMinneapolisMinnesota55404-
Englewood Health/Hematology Oncology Practice of Englewood (HOPE)EnglewoodNew Jersey07631-
Western Pennsylvania HospitalPittsburghPennsylvania15224-
Texas Oncology, P.A. - Fort WorthFort WorthTexas76104-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Little Rock, AR

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arkansas for Medical Sciences· Little Rock, ARMount Sinai Medical Center· Miami Beach, FLMinnesota Oncology Minneapolis· Minneapolis, MNEnglewood Health/Hematology Oncology Practice of Englewood (HOPE)· Englewood, NJWestern Pennsylvania Hospital· Pittsburgh, PATexas Oncology, P.A. - Fort Worth· Fort Worth, TX

Related Studies