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A Study of Giredestrant in Patients with Grade 1 Endometrial Cancer
EU CTIS ID: 2023-504091-23-00
What this study is testing
To evaluate the efficacy of giredestrant by regression rate at the Month 6 assessment and to evaluate the safety and tolerability of giredestrant
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Confirmed Grade 1 endometrial carcinoma (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
- 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
- Adequate hematologic and end-organ function
You likely can't join if
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 30 days after the final dose of giredestrant or within the time period specified per local prescribing guidelines after the final dose of the investigator’s choice of endocrine therapy
- Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6i, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
- Any gastrointestinal condition causing malabsorption or obstruction
- Planned surgery, either for the treatment of cancer or any other surgery, during the study treatment period and up to 10 days after the completion of study treatment
- Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis, current alcohol abuse, cirrhosis, or positive test for viral hepatitis
- Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant’s safe participation in and completion of the study
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Canada
- Australia
- United States
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Canada; Australia; United States; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.