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Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer

Efficacy of Oral Regorafenib Combined With Intra-muscular Injection of Fulvestrant in Patients With Recurrent Low-grade Serous Ovarian Cancer: A Phase II Single Arm Trial

NCT05113368•Sarah K. Lynam MD

View on ClinicalTrials.gov

Summary

To see how effective the study medicine combined with hormone therapy is when given to participants with recurrent low-grade serous ovarian cancer.

Detailed Description

Regorafenib is an investigational drug that works by interrupting the rapid and uncontrolled growth of cancer cells by stopping the signals that tell the cancer cells to grow and the ability of the cancer cells to form new blood vessels which they need to be able to grow. Treatment will continue until disease progression or unacceptable toxicities. For participants with a complete response to therapy, maintenance therapy with both drugs will be continued for 12 months.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subjects must have recurrent low-grade serous ovarian cancer.
•Up to 5 prior lines of therapy are allowed.
•Prior therapy with MEK inhibitors is allowed
•Prior therapy with aromatase inhibitors like letrozole is allowed
•Prior anti-angiogenesis therapy is not allowed except for bevacizumab.
•Subjects must have measurable disease based on RECIST 1.1 with at least one target lesion and with available archival tumor tissue.
•Subjects must have an ECOG performance status of 0-2.
•Age ≥ 18 years.
•Life expectancy of at least 12 weeks (3 months).
•Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
+9 more criteria

Exclusion Criteria

•Patients with sarcoma, carcinosarcoma or high grade carcinoma
•Any histology type other than low-grade serous histology
•Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
•Uncontrolled hypertension (systolic pressure \>150 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v5.0\] on repeated measurement) despite optimal medical management.
•Active or clinically significant cardiac disease including:
•* Congestive heart failure - New York Heart Association (NYHA) \> Class II.
•* Active coronary artery disease.
•* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
•* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization.
•Evidence or history of bleeding diathesis or coagulopathy.
+37 more criteria

Locations (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

June 28, 2022

Primary Completion Date

September 1, 2026

Completion Date

February 1, 2027

Last Updated

August 21, 2025

Enrollment

ESTIMATED participants

Conditions

Ovarian CancerSerous Ovarian Cancer

Interventions

Regorafenib

DRUG

Fulvestrant

DRUG

Contacts

Sarah Lynam, MD

CONTACT

1-800-641-2422 Sarah.Lynam@UHhospitals.org

Nancy Fusco, RN

CONTACT

216-844-3954 nancy.fusco@UHhospitals.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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