Actively Recruiting
Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer
Led by Sarah K. Lynam MD · Updated on 2025-08-21
31
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
S
Sarah K. Lynam MD
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
To see how effective the study medicine combined with hormone therapy is when given to participants with recurrent low-grade serous ovarian cancer.
CONDITIONS
Official Title
Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent low-grade serous ovarian cancer diagnosis
- Up to 5 prior lines of therapy allowed
- Prior treatment with MEK inhibitors allowed
- Prior aromatase inhibitor therapy (e.g., letrozole) allowed
- Prior anti-angiogenesis therapy not allowed except bevacizumab
- Measurable disease based on RECIST 1.1 with at least one target lesion
- Availability of archival tumor tissue
- ECOG performance status of 0 to 2
- Age 18 years or older
- Life expectancy of at least 12 weeks
- Ability and willingness to sign informed consent
- Adequate bone marrow, liver, and kidney function per specified lab tests
- Negative pregnancy test for women of childbearing potential within 7 days prior to treatment
- Use of adequate contraception from consent signing until 2 months after last dose
- Ability to swallow and retain oral medication
- Archival FFPE tumor tissue block or sufficient unstained slides available
You will not qualify if you...
- Sarcoma, carcinosarcoma, or high-grade carcinoma diagnosis
- Histology other than low-grade serous
- Previous participation in this study or permanent withdrawal from it
- Uncontrolled hypertension despite optimal treatment
- Significant active cardiac disease including congestive heart failure NYHA Class > II, active coronary artery disease, certain arrhythmias, unstable angina, or recent myocardial infarction
- History or evidence of bleeding disorders or recent major bleeding events
- Recent thrombotic or embolic events within 6 months
- Untreated or concurrent cancers except certain treated in-situ or nonmelanoma skin cancers
- Phaeochromocytoma diagnosis
- Active or treated HIV or hepatitis B/C infection not controlled on stable therapy
- Ongoing infection grade 2 or higher
- Symptomatic brain or meningeal tumors
- Non-healing wounds, ulcers, or bone fractures
- Major surgery or significant injury within 28 days prior to treatment
- Renal failure requiring dialysis
- Dehydration grade >1
- Seizure disorder requiring medication
- Persistent proteinuria grade 3 or higher
- Interstitial lung disease with symptoms
- Respiratory-compromising pleural effusion or ascites
- History of organ transplant
- Allergy or hypersensitivity to study drugs or components
- Malabsorption or significant gastrointestinal issues affecting oral medication
- Active or at-risk bowel perforation or fistula
- Pregnant or breastfeeding women
- Conditions making participation unsuitable
- Substance abuse or social conditions interfering with study
- Concurrent anti-cancer therapies except study drugs
- Prior regorafenib or similar multi-targeted kinase inhibitors
- Use of other investigational drugs or devices within 4 weeks
- Therapeutic anticoagulation with Vitamin-K antagonists or heparins requires close monitoring
- Use of herbal remedies like St. John's wort
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
S
Sarah Lynam, MD
CONTACT
N
Nancy Fusco, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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