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Kinase Inhibitor
Regorafenib for Glioblastoma
Phase 2
Waitlist Available
Led By David Peereboom, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib).
Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from start of treatment
Awards & highlights
Study Summary
This trial is testing a new drug, Regorafenib, to see if it is safe and tolerable for people with glioblastoma who have progressed on bevacizumab. 22 patients will be enrolled, and if they can tolerate the drug it will be given to them as monotherapy.
Who is the study for?
This trial is for adults with recurrent glioblastoma who have previously not responded to bevacizumab treatment. They must have certain blood and organ function levels, agree to use contraception if of childbearing potential, and cannot have other concurrent cancers (with some exceptions). Participants need a life expectancy of at least 12 weeks and should not be on any conflicting medications or treatments.Check my eligibility
What is being tested?
The study tests the safety and tolerability of Regorafenib, an FDA-approved drug, in patients with glioblastoma that has recurred after prior treatments including chemotherapy and radiotherapy. The trial will involve up to 22 participants who meet strict eligibility criteria.See study design
What are the potential side effects?
While specific side effects are not listed here, Regorafenib can commonly cause fatigue, hand-foot skin reactions, diarrhea, increased liver enzymes, hypertension, rash or other skin changes. Side effects vary by individual; some may experience more severe issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not receiving any cancer treatments other than the study treatment.
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My brain cancer has returned after treatment with radiation and chemotherapy.
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It's been over 3 weeks since my last non-cytotoxic therapy or non-nitrosourea chemo, or 6 weeks since any nitrosourea chemo.
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I am on blood thinners like warfarin.
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I have previously taken regorafenib.
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I am mostly able to care for myself and carry out daily activities.
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I am currently using herbal remedies like St. John's wort.
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My glioblastoma worsened after bevacizumab treatment.
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I can swallow and keep down pills.
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My kidney function, measured by creatinine, is within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median overall survival (OS)
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Median time to progression (TTP)
Objective response rate (ORR)
+1 moreSide 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%
pancreatic carcinoma
1%
Lung abscess
1%
Large intestine perforation
1%
Oesophagitis
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: RegorafenibExperimental Treatment1 Intervention
160 mg regorafenib 3 weeks on/ one week off in participants with Avastin refractory Glioblastoma, continued until progression or toxicity. Participants will receive an MRI every 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
453 Previous Clinical Trials
31,855 Total Patients Enrolled
15 Trials studying Glioblastoma
432 Patients Enrolled for Glioblastoma
David Peereboom, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
9 Previous Clinical Trials
389 Total Patients Enrolled
9 Trials studying Glioblastoma
389 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on blood thinners, but not warfarin, and have no history of bleeding disorders.I am not receiving any cancer treatments other than the study treatment.It has been over 3 weeks since my last non-nitrosourea chemotherapy.I have been on a stable or decreasing dose of corticosteroids, not exceeding 4mg/day.My brain cancer has returned after treatment with radiation and chemotherapy.I have been treated with Regorafenib before.I haven't had major surgery or significant injury in the last 4 weeks, or minor procedures in the last week.I have been diagnosed with phaeochromocytoma.I have serious heart rhythm problems not controlled by basic medications.It's been over 3 weeks since my last non-cytotoxic therapy or non-nitrosourea chemo, or 6 weeks since any nitrosourea chemo.I am willing and able to follow the study's requirements.I have a condition that affects how my body absorbs nutrients.I have high levels of protein in my urine.I am on blood thinners like warfarin.I do not have serious heart conditions.I have previously taken regorafenib.I have not had a stroke, mini-stroke, or lung clot in the past 6 months.I am mostly able to care for myself and carry out daily activities.I agree to use birth control from the start of the study until 2 months after the last dose.I have no other cancers, or if I do, they are either skin cancer treated with the intent to cure, early-stage cancers I've recovered from, or any cancer I've been free of for 3+ years.I do not have conditions that increase my risk of bleeding.I am currently using herbal remedies like St. John's wort.It has been at least 12 weeks since I finished my radiation treatment.You are expected to live for at least 3 more months.I agree to use birth control from the start of the study until 2 months after the last dose.My glioblastoma worsened after bevacizumab treatment.I can swallow and keep down pills.My blood pressure is not controlled even with medication.I have cirrhosis or active hepatitis.I do not have a serious ongoing infection.I currently have symptoms of interstitial lung disease.I am not pregnant or breastfeeding.My kidney function, measured by creatinine, is within normal limits.It has been over 3 weeks since my last non-chemotherapy treatment.It has been 6 weeks since I finished my chemotherapy that included nitrosourea.My heart failure is not severe, staying at or below NYHA Class II.I have had a heart attack, severe chest pain, or heart surgery in the last 6 months.I have been diagnosed with HIV.I do not have any severe illnesses that are not under control.I have not had severe bleeding in the last 4 weeks.I have a wound, ulcer, or bone fracture that hasn’t healed.I have fluid in my chest or abdomen causing significant breathing problems.I have not taken any cancer drugs recently.I am not pregnant or incapable of becoming pregnant.My cancer has come back no more than 3 times, and I may have been treated with bevacizumab.I have not had major surgery or a significant injury in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Regorafenib
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.
Are there any health risks associated with taking Regorafenib?
"While there is some evidence to support the safety of Regorafenib, it only received a 2 because Phase 2 trials have not yet found data to suggest that the medication is effective."
Answered by AI
Does Regorafenib have a history of positive clinical outcomes?
"As of now, 63 different research projects are underway that focus on Regorafenib. Out of those 63 active studies, 8 have reached Phase 3. Many of the trials taking place for this medication are based in Commack, New york; however, there are 1,301 total locations running these sorts of tests."
Answered by AI
Are new participants still being sought for this research?
"The clinicaltrials.gov website indicates that this trial is no longer recruiting patients, with the study having been initially posted on 7/31/2019 and last updated on 8/25/2022. There are, however, 1508 other studies currently underway which are actively enrolling participants."
Answered by AI
What makes this research stand out from similar investigations?
"63 different clinical trials for Regorafenib are currently underway in 424 cities and 30 countries. The first trial began in 2013 with 11 participants, all of whom completed Phase 2 drug approval. 82 trials have been conducted in total since the initial study."
Answered by AI
How many study participants are included in the clinical trial?
"This particular study is no longer recruiting patients, but there are plenty of other active trials that might be a fit. 1445 studies are currently searching for glioblastoma patients and 63 studies are enrolling participants for Regorafenib trials."
Answered by AI
What medical conditions has Regorafenib been shown to be effective in treating?
"Regorafenib has been shown to be effective in treating patients that have previously received anti-vegf therapy, those with advance directives, and sorafenib."
Answered by AI
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