Trials / Active Not Recruiting
Active Not RecruitingNCT05634499
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
A Phase II, Single-Arm Study of Giredestrant in Patients With Grade 1 Endometrial Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Giredestrant | 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. |
Timeline
- Start date
- 2023-06-27
- Primary completion
- 2026-08-28
- Completion
- 2026-08-28
- First posted
- 2022-12-02
- Last updated
- 2026-04-13
Locations
12 sites across 4 countries: United States, Canada, Italy, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05634499. Inclusion in this directory is not an endorsement.