Trial Title:
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
NCT ID:
NCT05634499
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Giredestrant
Description:
Participants will receive giredestrant 30 milligrams (mg) taken orally (PO) once a day
(QD) on Days 1 to 28 of each 28-day cycle for 6 cycles. After completion of 6 cycles, the
participant and investigator can choose to continue study treatment for an additional 18
cycles or discontinue study treatment and receive investigator-determined care.
Arm group label:
Giredestrant
Other name:
RO7197597
Other name:
GDC-9545
Other name:
RG6171
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute
Address:
City:
Little Rock
Zip:
72205
Country:
United States
Facility:
Name:
Mount Sinai Medical Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Facility:
Name:
Minnesota Oncology Minneapolis
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Facility:
Name:
Englewood Health/Hematology Oncology Practice of Englewood (HOPE)
Address:
City:
Englewood
Zip:
07631
Country:
United States
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Facility:
Name:
Western Pennsylvania Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Facility:
Name:
Texas Oncology, P.A. - Fort Worth
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Facility:
Name:
McGill University Health Centre - Glen Site
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Facility:
Name:
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Facility:
Name:
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
Address:
City:
Gliwice
Zip:
44-101
Country:
Poland
Facility:
Name:
Swietokrzyskie Centrum Onkologii; Klinika Ginekologii
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Facility:
Name:
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Start date:
June 27, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05634499
