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Ovarian CancerPhase 2NCT05113368

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

A Phase 2 study testing Regorafenib and Fulvestrant in people with Ovarian Cancer and Serous Ovarian Cancer, run by Sarah K. Lynam MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Serous Ovarian Cancer
What is being tested?
Regorafenib and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
28 Jun 2022to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
  • Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate amino-transferease (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Alkaline phosphastase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Serum creatinine ≤ 1.5 x the ULN
  • International normalized ratio (INR)/ Partial thromboplastin time (PTT) ≤ 1.5 x ULN. (Subjects who are treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.
  • Platelet count >100000 /mm3, hemoglobin (Hb) >9 g/dL, absolute neutrophil count (ANC)> 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
  • Subjects (women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
  • Subject must be able to swallow and retain oral medication. o Availability of an archival FFPE tumor tissue block from primary diagnosis specimen, metastatic, or recurrent site. If an FFPE tissue block cannot be provided then 15 unstained slides (10 minimum) will be acceptable along with 1 H\&E stained slide.

Who cannot join

  • 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.
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  • 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.
  • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment within 6 months of informed consent.
  • Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed. All cancer treatments must be completed at least 3 years prior to registration.
  • Patients with phaeochromocytoma.
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy. However, patients with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy and patients with chronic hepatitis B or C infection with undetectable viral load by PCR and on a stable regimen of antiretroviral therapy would be eligible.
  • Ongoing infection >= Grade 2 NCI-CTCAE v5.0.
  • Symptomatic metastatic brain or meningeal tumors.
  • Presence of a non-healing wound, non-healing ulcer, or bone fracture.
  • Major surgical procedure or significant traumatic injury within 28 days before start of study medication
  • Renal failure requiring hemo-or peritoneal dialysis.
  • Dehydration Grade >1 NCI-CTCAE v5.0.
  • Patients with seizure disorder requiring medication.
  • Persistent proteinuria >= Grade 3 NCI-CTCAE v5.0 (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 5.0 Grade 2 dyspnea).
  • History of organ allograft (including corneal transplant). Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
  • Any malabsorption condition.
  • 1. Gastrointestinal abnormalities including:
  • Inability to take oral medication;
  • Requirement for intravenous alimentation;
  • Treatment for active peptic ulcer disease in the past 6 months;
  • Active gastrointestinal bleeding, unrelated to cancer, as evidenced by clinically significant hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
  • Active bowel obstruction (with or without gastrostomy tube) or inability to take oral medications
  • Patients with an active or at risk for bowel perforation or fistula
  • Women who are pregnant or breastfeeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib combined with fulvestrant).
  • Prior use of regorafenib or other agents with similar multi-targeted kinase activity.
  • Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
  • Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin) or with heparins and heparinoids are permitted but should be monitored carefully and closely.
  • o However, prophylactic anticoagulation as described below is allowed:
  • Infrequent bleeding or elevations in PT-INR have been reported in some subjects taking warfarin while on regorafenib therapy. Therefore, subjects taking concomitant warfarin should be monitored regularly for changes in PT, PT-INR or clinical bleeding episodes.
  • Low dose aspirin (<= 100 mg daily).
  • Prophylactic doses of heparin.
  • Use of any herbal remedy (e.g. St. John's wort [Hypericum perforatum])

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah Lynam, MD contact

1-800-641-2422

Sarah.Lynam@UHhospitals.org

Nancy Fusco, RN contact

216-844-3954

nancy.fusco@UHhospitals.org

United States1 site, 1 recruiting

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

    Cleveland, Ohio, 44106

    Sarah M Lynam, MD, 800-641-2422, Sarah.Lynam@UHhospitals.org

    Recruiting

Other trials in United States

About this study

Official title: 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

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

Read the 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.

Keywords
Ovarian Cancer, serous ovarian cancer, Fulvestrant, Regorafenib
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Oral regorafenib in a ReDOSplan (80 mg week#1, 120 mg week#2, 160 mg week#3 for cycle #1 then adjust final dose for subsequent cycles based on tolerance during cycle #1) [3 weeks on/1 week off] combined with intramuscular injection of fulvestrant 500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities

  • FulvestrantDrug

    500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities

Study groups in NCT05113368
Study groupRoleWhat they receive
Oral Regorafenib combined with intra-muscular injection of FulvestrantExperimentalOral regorafenib in a ReDOS plan (80 mg week#1, 120 mg week#2, 160 mg week#3 for cycle #1 then adjust final dose for subsequent cycles based on tolerance during cycle #1) [3 weeks on/1 week off] combined with intramuscular injection of fulvestrant 500 mg day #1 (day #15 will be planned only in cycle #1) in a 28-day cycle till disease progression or unacceptable toxicities
Receives: Drug: Regorafenib; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate of the Drug Regimen

    To assess the efficacy of this regimen in term of overall objective response rate (complete response rate) at 12 weeks as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

    The number of participants that reach a complete response (CR) defined as normalization of tumor markers, tumor nodes <10 mm.

    Measured: 12 weeks from first cycle of treatment (each cycle is 28 days)

  2. Partial Response Rate of the Drug Regimen

    To assess the efficacy of this regimen in term of overall objective response rate (partial response rate) at 12 weeks as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

    The number of participants that reach a partial response (PR)defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: 12 weeks from first cycle of treatment (each cycle is 28 days)

Secondary outcomes (4)

  1. Overall Survival in Months

    To assess overall survival in months from enrollment to date of last follow up or death. The number of participants still alive at end of study.

    Measured: up to 3 years from start of study

  2. Progression-free Survival in Months

    To assess progression-free survival in months from enrollment to date of documented disease progression or death. The number of participants still alive at end of study.

    Measured: up to 3 years from start of study

  3. Clinical Benefit Rate

    To assess clinical benefit rate (objective response and stable disease)at 12 weeks.

    Measured: 12 weeks

  4. Assess Toxicity of this Combined Regime

    The number of participants that have grade 3 and 4 related toxicities. Adverse Events will be characterized by type, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v.5.03), timing, seriousness, and relationship to study therapy.

    Measured: at 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start28 Jun 2022
  3. Primary completionSep 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05113368
Sponsor's protocol ID
CASE2820
Status last verified
Aug 2025
First submitted
26 Sep 2021
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie or influence the results observed in this study

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib and Fulvestrant in people with Ovarian Cancer and Serous Ovarian Cancer, run by Sarah K. Lynam MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Lynam, MD (1-800-641-2422, Sarah.Lynam@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate of the Drug Regimen (time frame: 12 weeks from first cycle of treatment (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05113368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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