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A clinical trial to look at how well giredestrant works in people with Stage 1, Grade 1 endometrial cancer, how safe giredestrant is and to understand the way the body processes giredestrant
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
- Cancer
- Endometrial Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Countries
- Canada
- Italy
- Poland
- United States
Trial Identifier:
NCT05634499 2022-002443-21 CO44195
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05634499,CO44195,2022-002443-21
Trial Identifier
Female
Gender
≥18 Years
Age
No
Healthy Volunteers
1. Why is the endomERA clinical trial needed?
The uterus (womb) is an organ where a baby is carried during pregnancy. The inner layer of the uterus is called the endometrium, or lining, and endometrial cancer occurs when the cells of this lining grow out of control. A high level of a hormone called oestrogen is one of the main things that drive endometrial cancer. Cancers are described based on how much and how fast they grow. Endometrial cancer that has not spread outside the uterus is known as ‘Stage 1’ endometrial cancer. ‘Grade 1’ endometrial cancer cells are similar to normal cells and tend to grow slowly. Endometrial cancer, which is Stage 1 and Grade 1, is considered low-risk.
Standard treatment for endometrial cancer is surgery to remove the uterus (hysterectomy). Women who have had a hysterectomy can no longer become pregnant. However, women who have been diagnosed with Grade 1 endometrial cancer and who are not able to or prefer not to have immediate surgery or who would like to have children can be offered hormone therapy to block oestrogen to delay surgery. Better oestrogen-blocking treatments are needed for people with endometrial cancer.
Giredestrant is a new drug designed to block oestrogen. Giredestrant is an experimental medicine, which means health authorities have not approved giredestrant for the treatment of endometrial cancer.
This clinical trial will look at the safety and effectiveness of giredestrant in people with Stage 1, Grade 1 endometrial cancer and how the body processes giredestrant.
2. How does the endomERA clinical trial work?
This clinical trial is recruiting people who have a health condition called Stage 1, Grade 1 endometrial cancer. People can take part if they have not previously received treatment for endometrial cancer or for conditions that can develop into endometrial cancer (known as endometrial hyperplasia and endometrial intraepithelial neoplasia), and they are willing to delay a hysterectomy for 6 months.
The purpose of this clinical trial is to look at the effects, good or bad, of giredestrant in participants with endometrial cancer and to understand how the body processes giredestrant.
Participants will be given the clinical trial treatment giredestrant as a pill (to be swallowed) once every day over 6 months, in 28-day treatment periods (called treatment ‘cycles’) until they have completed 6 treatment cycles. After 6 treatment cycles, participants and their clinical trial doctor can choose to be given alternative standard treatment (such as surgery) or to continue the clinical trial treatment for up to 18 more treatment cycles.
Participants will be seen by the clinical trial doctor on Day 1 of each treatment cycle, and 1 month after the last dose of clinical trial treatment has been given. These hospital visits will include checks to see how the participant is responding to the treatment (including by taking a sample of endometrium cells, known as a ‘biopsy’, at the start of the trial and at Months 3 and 6) and discussing any side effects they may be having. Participants’ total time in the clinical trial will be approximately 8 months to more than 2 years (26 months). Participants are free to stop trial treatment and leave the clinical trial at any time.
3. What are the main endpoints of the endomERA clinical trial?
The main clinical trial endpoints (the main results that are measured in the trial to see if the treatment has worked) are:
● The number of participants who have a decrease in cancer cells or an increase in non-cancer or non-hyperplasia cells (known as ‘regression’) in a biopsy of their endometrium taken at Month 6 compared with the start of the trial, and
● The number and seriousness of any side effects
The other clinical trial endpoints include:
● How many participants have no cancer or hyperplasia cells in their biopsy at Month 6 (complete regression rate)
● How much time is there between the participant’s first regression and the cancer getting worse
● How much time is there between starting the trial treatment and the participant’s first regression
● How much time is there between starting the trial treatment and the participant’s cancer getting worse
● How the body processes giredestrant
4. Who can take part in this clinical trial?
People can take part in this trial if they are over 18 years of age and have been diagnosed with Stage 1, Grade 1 endometrial cancer. Participants must also be willing to be given clinical trial treatment for 6 months before a decision to have surgery is made and to have endometrial biopsies taken throughout the trial.
People may not be able to take part in this trial if they:
● Have previously received treatment for endometrial cancer, endometrial hyperplasia or endometrial intraepithelial neoplasia
● Have previously received other certain treatments, including treatments for cancer, such as chemotherapy, within a specific timeframe before starting the trial
● Have certain other medical conditions, including conditions that affect the digestive system or liver, or certain infections
● Are not able to swallow pills
● Are pregnant or breastfeeding or are planning to become pregnant during the trial or within 10 days of completing the clinical trial treatment
5. What treatment will participants be given in this clinical trial?
Everyone who joins this clinical trial will be given giredestrant as a pill to be swallowed every day on Days 1–28 of each 28-day treatment cycle for at least 6 treatment cycles.
This is an ‘open-label’ clinical trial, which means that both participants and the clinical trial doctor will know which treatment participants have been given.
6. Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.
Risks associated with the clinical trial drug
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drug used in this clinical trial. Side effects can be mild to severe and even life-threatening and can vary from person to person.
Giredestrant
Potential participants will be told about the known side effects of giredestrant and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs.
Giredestrant will be given as a pill (to be swallowed). Participants will be told about any known side effects of swallowing pills.
Potential benefits associated with the clinical trial
Participants' health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.
For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT05634499
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05634499,CO44195,2022-002443-21
Trial Identifier
Giredestrant
Treatments
Endometrial Cancer
Condition
Official Title
A Phase II, Single-Arm Study of Giredestrant in Patients With Grade 1 Endometrial Cancer
Eligibility Criteria
Female
Gender
≥18 Years
Age
No
Healthy Volunteers
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 treatment period and for 30 days after the final dose of giredestrant, as defined in the protocol
Exclusion Criteria
- 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
- Participants with non-endometrioid histologies, such as serous, clear cell, and mixed
- Treatment with investigational therapy within 28 days prior to initiation of study enrollment
- Treatment for cancer including but not limited to, chemotherapy, immunotherapy, cyclin-dependent kinase (CDK)4/6 inhibitors, endocrine therapy, biologic therapy, or herbal therapy within 28 days prior to the initiation of study enrollment
- Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
- Known hypersensitivity to giredestrant or its excipients
- Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements
- Evidence or high suspicion of metastatic/extrauterine disease at enrollment
- Unwilling or unable to comply with study-related procedures, including all endometrial sampling/biopsies
- 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
- Serious infections requiring IV antibiotics within 7 days prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact participant safety
- Participants who have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis, as defined in the protocol
- Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant's safe participation in and completion of the study
- History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death (e.g., 5-year overall survival 90%) after curative treatment
- Active tuberculosis
- Severe infection per investigator judgment at the time of enrollment, including but not limited to, use of systemic antibiotics, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety
- Significant cardiovascular disease, such as cardiac disease New York Heart Association Class II or greater, myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
- Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
- Major surgical procedure other than for diagnosis within 28 days prior to enrollment or anticipation of need for a major surgical procedure during the study
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high risk for treatment complications illnesses or conditions that interfere with the participant's capacity to understand, follow, and/or comply with study procedures
For the latest version of this information please go to www.forpatients.roche.com