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Hormone Therapy
Regorafenib + Fulvestrant for Ovarian Cancer
Phase 2
Recruiting
Led By Kristine Zanotti, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from start of study
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years from start of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from start of study
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 moreOther outcome measures
Identify genomic related markers
Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT0202460782%
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%
Lung abscess
1%
Oesophagitis
1%
Large intestine perforation
1%
pancreatic carcinoma
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
~3690
Find a Location
Who is running the clinical trial?
Sarah K. Lynam MDLead Sponsor
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,746 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a wound, ulcer, or bone fracture that is not healing.Your bilirubin levels are not too high.I need to be fed through my veins.My blood counts meet the required levels without transfusions.I have had an organ transplant or am allergic to the study drugs.My blood clotting tests are within the normal range, or I am monitored closely if on blood thinners.I cannot take medicine by mouth.I have previously used regorafenib or similar medications.I haven't had major surgery or a serious injury in the last 28 days.I am not using any herbal remedies like St. John's wort.Your alkaline phosphatase levels must be within a certain range, unless you have liver involvement in your cancer.I do not have severe breathing problems due to fluid in my chest or abdomen.I am on blood thinners like warfarin or heparin and am monitored closely.I do not have severe dehydration.My blood, liver, and kidney tests are within normal ranges.I am taking low doses of heparin to prevent blood clots.I do not have any major issues with my digestive system.I am on warfarin and understand I need regular monitoring for bleeding or changes in blood tests while on regorafenib.I do not have a current infection or it is mild.I have not had severe bleeding in the last 4 weeks.I can provide a tissue sample from my cancer diagnosis or have at least 10 slides available.I have been diagnosed with phaeochromocytoma.I am on medication for irregular heartbeats not including beta blockers or digoxin.I have previously been treated with drugs like letrozole.I have been treated with MEK inhibitors before.I have not received any anti-angiogenesis therapy except for bevacizumab.I have brain or meningeal tumors that are causing symptoms.I have a tumor that can be measured and there is tissue from it saved for testing.I haven't had any blood clot issues like a stroke or deep vein thrombosis in the last 6 months.My liver enzymes are within the required limits.My urine tests show very high protein levels.My high blood pressure is not controlled even with medication.Your kidney function, measured by a blood test, is within a certain range.My cancer is not low-grade serous type.I am on medication for seizures.I have no other cancers, or any I had were treated over 3 years ago and not returned.I have a history of bleeding disorders or blood clotting issues.I am at risk for or have an active bowel perforation or fistula.I cannot take pills by mouth due to a blockage in my intestines.I am not receiving any cancer treatments other than regorafenib with fulvestrant.I can swallow and keep down pills.I can take care of myself and am up and about more than half of my waking hours.I have HIV or hepatitis B/C but it's under control with no current infections.I am 18 years old or older.I am not pregnant or breastfeeding.I have been diagnosed with sarcoma, carcinosarcoma, or high grade carcinoma.I do not have any serious heart conditions.I require dialysis for kidney failure.My heart condition does not severely limit my daily activities.I am on blood thinners for prevention.I currently have symptoms of interstitial lung disease.I have a condition that affects how my body absorbs nutrients.I have not had major surgery or a serious injury in the last 28 days.I take 100 mg or less of aspirin daily.I have had up to 5 previous treatments for my condition.I am not pregnant or incapable of becoming pregnant.I have active heart disease related to my arteries.My ovarian cancer has come back and is low-grade.I have not had a heart attack or unstable chest pain in the last 6 months.I have been treated for an active stomach ulcer in the last 6 months.I have had serious GI bleeding not caused by cancer in the last 3 months without proof of it being resolved.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Regorafenib combined with intra-muscular injection of Fulvestrant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still ongoing for this medical experiment?
"This medical experiment, which was created on September 1st 2022 and revised April 17th of the same year, is not currently accepting participants. Nevertheless, there are 868 other clinical trials in progress that may require volunteers."
Answered by AI
What risks do individuals run when using Regorafenib?
"Our team has appraised the safety of Regorafenib as a 2 due to its status in Phase 2 trials, which reflects evidence concerning safety yet no data regarding efficacy."
Answered by AI
Can you provide details on the other investigations involving Regorafenib?
"Presently, there are 39 Regorafenib trials in Phase 3 of the research process and 191 active studies being conducted overall. Most of these medical investigations originate out of Shanghai; however, a total of 6999 clinical sites worldwide are taking part in researching this drug."
Answered by AI
What are the chief applications of Regorafenib?
"Regorafenib, in addition to being used for conditions previously treated with anti-VEGF therapies, may also be prescribed to address metastatic colorectal cancer (CRC), PIK3CA gene mutation and Sorafenib."
Answered by AI
What is the current enrolment capacity for this research endeavor?
"Unfortunately, this clinical trial is not accepting patients at the moment. It was initially launched on September 1st 2022 and most recently modified on April 17th 2022. If you're still looking for options, 677 studies searching for ovarian cancer participants are enrolling presently as well as 191 trials recruiting volunteers to test Regorafenib."
Answered by AI
What objectives have been established for this research?
"This medical trial will be monitored for 12 weeks, with each cycle of treatment lasting 28 days. The primary outcome being measured is the Drug Regimen's Partial Response Rate, while secondary outcomes measure Overall Survival in Months, Clinical Benefit Rate and Progression-free Survival in Months."
Answered by AI
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