A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer (NCT05634499) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
United States30 participantsStarted 2023-06-27
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed Grade 1 endometrial cancer (EC) of endometrioid histology for which participants are willing to receive 6-cycles of study therapy. An endometrial biopsy (EMB) or dilation and curettage (D\&C) fresh collected within the screening period or archival sample collected within 3 months prior to screening must be provided to a central laboratory for histologic confirmation to determine eligibility.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor (\<50% myometrial invasion)
* MRI or computed tomography (CT)-confirmation of no extrauterine disease
* Willing to undergo a minimum of 6 continuous cycles of therapy before decision on surgery
* No prior treatment for endometrial cancer
* Able and willing to take oral medications
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Adequate hematologic and end-organ function, as defined in the protocol
* Negative HIV test at screening, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥200/μL, and have an undetectable viral load.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatmen…
What they're measuring
1
Percentage of Participants Who Have Regression at 6 Months
Timeframe: Baseline, 6 Months
2
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)
Timeframe: From Baseline until 30 days after the final dose of study drug (up to 1 year, 6 months)