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Hormone Therapy

Regorafenib + Fulvestrant for Ovarian Cancer

Phase 2
Recruiting
Led By Sarah Lynam, MD
Research Sponsored by Sarah K. Lynam MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Prior anti-angiogenesis therapy is not allowed except for bevacizumab.
Must not have
Presence of a non-healing wound, non-healing ulcer, or bone fracture.
Requirement for intravenous alimentation;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from start of study
Awards & highlights

Summary

This trial is testing how well the study medicine works when given with hormone therapy to people with ovarian cancer that has come back.

Who is the study for?
This trial is for adults over 18 with recurrent low-grade serous ovarian cancer who've had up to five previous treatments, including MEK inhibitors and aromatase inhibitors. They must have measurable disease, be in a stable health condition (ECOG 0-2), not pregnant or breastfeeding, willing to use contraception, and able to take oral meds. Exclusions include other cancer types or significant health issues like uncontrolled hypertension or recent major surgeries.Check my eligibility
What is being tested?
The effectiveness of Regorafenib combined with Fulvestrant hormone therapy is being tested on participants with recurrent low-grade serous ovarian cancer. The study aims to see if this combination improves outcomes compared to current standard treatments.See study design
What are the potential side effects?
Potential side effects may include high blood pressure, fatigue, hand-foot skin reactions (redness and pain on palms or soles), diarrhea, decreased appetite, infection risks due to lowered immune function, voice changes (hoarseness), increased liver enzymes indicating liver injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts meet the required levels without transfusions.
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I have not received any anti-angiogenesis therapy except for bevacizumab.
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I have a tumor that can be measured and there is tissue from it saved for testing.
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I can swallow and keep down pills.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My ovarian cancer has come back and is low-grade.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a wound, ulcer, or bone fracture that is not healing.
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I need to be fed through my veins.
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I have had an organ transplant or am allergic to the study drugs.
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I am on medication for irregular heartbeats not including beta blockers or digoxin.
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I cannot take medicine by mouth.
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I have previously used regorafenib or similar medications.
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I am not using any herbal remedies like St. John's wort.
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I do not have severe breathing problems due to fluid in my chest or abdomen.
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I do not have severe dehydration.
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I am taking low doses of heparin to prevent blood clots.
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I do not have a current infection or it is mild.
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I have not had severe bleeding in the last 4 weeks.
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I have been diagnosed with phaeochromocytoma.
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I have brain or meningeal tumors that are causing symptoms.
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My urine tests show very high protein levels.
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My high blood pressure is not controlled even with medication.
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My cancer is not low-grade serous type.
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I am on medication for seizures.
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I have a history of bleeding disorders or blood clotting issues.
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I am at risk for or have an active bowel perforation or fistula.
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I cannot take pills by mouth due to a blockage in my intestines.
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I am not receiving any cancer treatments other than regorafenib with fulvestrant.
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I am not pregnant or breastfeeding.
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I have been diagnosed with sarcoma, carcinosarcoma, or high grade carcinoma.
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I do not have any serious heart conditions.
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I require dialysis for kidney failure.
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My heart condition does not severely limit my daily activities.
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I currently have symptoms of interstitial lung disease.
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I have a condition that affects how my body absorbs nutrients.
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I have not had major surgery or a serious injury in the last 28 days.
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I take 100 mg or less of aspirin daily.
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I have active heart disease related to my arteries.
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I have been treated for an active stomach ulcer in the last 6 months.
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I have had serious GI bleeding not caused by cancer in the last 3 months without proof of it being resolved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from start of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from start of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate of the Drug Regimen
Partial Response Rate of the Drug Regimen
Secondary outcome measures
Assess Toxicity of this Combined Regime
Clinical Benefit Rate
Overall Survival in Months
+1 more
Other outcome measures
Identify genomic related markers

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607
82%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
pancreatic carcinoma
1%
Large intestine perforation
1%
Oesophagitis
1%
Lung abscess
1%
embolism
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral Regorafenib combined with intra-muscular injection of FulvestrantExperimental Treatment2 Interventions
Oral 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580
Fulvestrant
2011
Completed Phase 3
~3810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian cancer include chemotherapy, targeted therapy, and hormone therapy. Chemotherapy agents like paclitaxel and carboplatin disrupt cell division, leading to cancer cell death. Targeted therapies, such as PARP inhibitors, exploit genetic vulnerabilities in cancer cells to prevent DNA repair and induce cell death. Hormone therapies, like fulvestrant, block hormone receptors or decrease hormone production, which is crucial for hormone-sensitive cancers like low-grade serous ovarian cancer. Understanding these mechanisms helps tailor treatments to specific cancer types, potentially improving outcomes and minimizing side effects.

Find a Location

Who is running the clinical trial?

Sarah K. Lynam MDLead Sponsor
BayerIndustry Sponsor
2,251 Previous Clinical Trials
25,336,885 Total Patients Enrolled
8 Trials studying Ovarian Cancer
365 Patients Enrolled for Ovarian Cancer
Afshin Dowlati, MDLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05113368 — Phase 2
Ovarian Cancer Research Study Groups: Oral Regorafenib combined with intra-muscular injection of Fulvestrant
Ovarian Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT05113368 — Phase 2
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113368 — Phase 2
~10 spots leftby Jul 2025