A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer (EndomERA)

Roche

Status and phase

Active, not recruiting

Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: Giredestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT05634499

CO44195

2023-504091-23-00 (Other Identifier)

2022-002443-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

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