Study of Giredestrant for Patients with Grade 1 Endometrial Cancer

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What is this study about?

This study is focusing on Grade 1 Endometrial Cancer. This is a type of cancer that begins in the lining of the uterus. The treatment being tested is a drug called Giredestrant, which is taken in the form of hard capsules. The purpose of the study is to see how well Giredestrant works in treating this type of cancer and to observe any side effects it may cause.

Participants in the study will receive Giredestrant and undergo regular assessments to monitor how the cancer responds to the treatment. The main goal is to evaluate the reduction in cancer at a 6-month check, alongside the safety of the drug. More detailed assessments will include checking the extent of cancer regression and monitoring its duration, as well as collecting blood samples to measure the amount of Giredestrant in the body at specified times.

This trial does not use a comparison group receiving a placebo, meaning all participants will be administered the active treatment. Patients will provide samples before and during the study for more comprehensive examination, including scans such as MRI or CT to monitor the presence and spread of the cancer. The information gained from this study may help in understanding how effective Giredestrant is as a therapy for this specific cancer type.

1 joining the study

Upon joining the study, eligibility is confirmed through specific criteria. This includes a performance status assessment and confirmation of Grade 1 endometrial cancer through a biopsy or similar procedure.

Imaging tests such as MRI or CT scans are conducted to confirm the absence of deeply invasive tumors and extrauterine disease.

2 treatment initiation

The treatment involves taking a medication called giredestrant, which is provided in the form of a hard capsule.

The medication is taken orally, and the treatment consists of a minimum of 6 continuous cycles before any decision regarding surgery is made.

3 treatment monitoring

Throughout the treatment, regular assessments are conducted to monitor the regression of cancer. The primary goal is to evaluate the regression rate at the 6-month mark.

Safety and tolerability of the medication are also closely monitored, with any adverse events being recorded and assessed.

4 evaluation at month 6

At the 6-month assessment, the primary endpoint is to determine the regression rate, which involves measuring the decrease in cancer proportion or the increase in non-cancerous tissue.

Secondary endpoints include complete regression rate, duration of regression, and time to regression or relapse.

5 end of study participation

The study is estimated to conclude by March 2025. Participants may undergo surgery after the 6-month assessment if deemed necessary.

Final evaluations include measuring the plasma concentration of giredestrant at specified time points to understand its effects better.

Who Can Join the Study?

Must have a Grade 1 Endometrial Cancer, which is a type of cancer that starts in the lining of the uterus.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
Must have a confirmed diagnosis of Grade 1 endometrial carcinoma of endometrioid histology, which is a specific type of cancer cell, and be willing to receive 6 cycles of study therapy.
Must provide a recent endometrial biopsy (EMB) or dilation and curettage (D&C) sample for lab confirmation. These are procedures to collect tissue from the uterus for testing.
Must have a magnetic resonance imaging (MRI) showing the tumor does not deeply invade the muscle of the uterus (less than 50% invasion).
Must have an MRI or computed tomography (CT) scan showing no cancer outside the uterus.
Must be willing to undergo at least 6 continuous cycles of therapy before deciding on surgery.
Must have adequate hematologic and end-organ function, meaning the blood and major organs are working well enough.
Must be within the specified age range for the study.
Both females and males can participate.

Who Cannot Join the Study?

Patients with a different type of cancer other than Grade 1 Endometrial Cancer cannot participate. Endometrial Cancer is a type of cancer that starts in the lining of the uterus.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medication or similar medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Iunzomwy Rolluknxp Prt Lc Sfyndj Dbi Tkjrsv Doih Anqrmge Iamz Stjjwm	Meldola	Italy
Nebcxbey Izynbged Ojkmswfpx Iou Mlfwu Ssvwbnxmefillyodjlbkthirbikl Ijduwfru Blpcttgk	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	31.07.2023
Poland	Not recruiting	31.07.2023

Trial locations

Investigated drugs:

Giredestrant

Giredestrant is a medication being studied for its effectiveness in treating patients with Grade 1 endometrial cancer. The trial aims to see how well this medication can reduce the size of the cancer by the sixth month of treatment. Additionally, the study will assess how safe and tolerable the medication is for patients.

Investigated diseases:

Grade 1 Endometrial Cancer – This is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is considered an early stage of endometrial cancer, where the cancer cells are well-differentiated and resemble normal cells. The progression of this cancer is typically slow, and it may remain confined to the uterus for some time. Symptoms can include abnormal vaginal bleeding or discharge, especially after menopause. As the disease progresses, it may cause pelvic pain or a mass in the pelvic area. Early detection often leads to better management of the condition.

Trial ID:

2023-504091-23-00

Protocol code:

CO44195

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Giredestrant for Patients with Grade 1 Endometrial Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?