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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05634499
Recruitment Status : Recruiting
First Posted : December 2, 2022
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Giredestrant Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-Arm Study of Giredestrant in Patients With Grade 1 Endometrial Cancer
Estimated Study Start Date : April 20, 2023
Estimated Primary Completion Date : June 15, 2024
Estimated Study Completion Date : September 15, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Giredestrant Drug: Giredestrant
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 therapy or discontinue study therapy and receive investigator-determined care. After 6 months, participants can discontinue study treatment and undergo surgery or continue to receive study treatment for up to 18 additional cycles, per shared decision-making by the participant and physician.
Other Names:
  • RO7197597
  • GDC-9545
  • RG6171


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Have Regression by 6 Months [ Time Frame: From Baseline to 6 Months ]
    The percentage of participants who have regression is defined as participants who have a decrease in the proportion of cancer in their endometrial biopsy or have an increase in non-cancer/non-atypical hyperplasia by the 6-month assessment compared with baseline.


Secondary Outcome Measures :
  1. Percentage of Participants Who Have Complete Regression by 6 Months [ Time Frame: From Baseline to 6 Months ]
    The percentage of participants who have complete regression is defined as participants having an assessment of 100% of non-cancer/non-atypical hyperplasia by the Month 6 assessment.

  2. Duration of Regression [ Time Frame: From the time of first regression to the time of the first relapse (up to 1 year, 6 months) ]
  3. Time to First Regression [ Time Frame: From first study treatment to the time of first regression (up to 1 year, 6 months) ]
  4. Time to Relapse or Loss of Clinical Benefit [ Time Frame: From first study treatment to relapse or loss of clinical benefit, whichever occurs first (up to 1 year, 6 months) ]
  5. Number of Participants with at Least One Adverse Event, with Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0) [ Time Frame: From Baseline until 30 days after the final dose of study drug (up to 1 year, 7 months) ]
  6. Plasma Concentration of Giredestrant at Specified Timepoints [ Time Frame: Predose on Day 1 of Cycles 1, 2, 3, 4, and 6; 3-4 hours Postdose on Day 1 of Cycles 1 and 2 (each cycle is 28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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) sample must be provided within 2 months of enrollment to a central laboratory for histologic confirmation to determine eligibility.
  • Life expectancy ≥12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Magnetic resonance imaging (MRI)-confirmation of non-deeply invasive tumor
  • 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 complex endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN), or 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
  • 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 10 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 10 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)
  • Has been on any hormonal treatment (including progestin-containing intrauterine device [IUD]) for complex atypical hyperplasia (CAH)/EIN or Grade 1 EC in the last 3 months
  • Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e., black cohosh) or has been on progestin (including progestin-containing IUD), tamoxifen or aromatase inhibitor within the prior 3 months
  • 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 9 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
  • Substance abuse within 12 months prior to screening
  • 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
  • Participants with known coronary artery disease, congestive heart failure not meeting the above criterion or with a left ventricular ejection fraction 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05634499


Contacts
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Contact: Reference Study ID Number: CO44195 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, New Jersey
Englewood Health/Hematology Oncology Practice of Englewood (HOPE) Recruiting
Englewood, New Jersey, United States, 07631
Poland
Swietokrzyskie Centrum Onkologii; Klinika Ginekologii Recruiting
Kielce, Poland, 25-734
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05634499    
Other Study ID Numbers: CO44195
2022-002443-21 ( EudraCT Number )
First Posted: December 2, 2022    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases