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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.

Must not have

Patients who are currently receiving anticoagulation treatment (warfarin is not allowed, low weight heparin is allowed). Evidence or history of bleeding diathesis or coagulopathy.

Patients who have had previous treatment with Regorafenib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from start of treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on blood thinners, but not warfarin, and have no history of bleeding disorders.

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I have been treated with Regorafenib before.

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I have been diagnosed with phaeochromocytoma.

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I have serious heart rhythm problems not controlled by basic medications.

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I have a condition that affects how my body absorbs nutrients.

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I have high levels of protein in my urine.

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I do not have serious heart conditions.

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I do not have conditions that increase my risk of bleeding.

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My blood pressure is not controlled even with medication.

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I have cirrhosis or active hepatitis.

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I do not have a serious ongoing infection.

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I currently have symptoms of interstitial lung disease.

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I am not pregnant or breastfeeding.

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My heart failure is not severe, staying at or below NYHA Class II.

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I have been diagnosed with HIV.

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I do not have any severe illnesses that are not under control.

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I have not had severe bleeding in the last 4 weeks.

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I have a wound, ulcer, or bone fracture that hasn’t healed.

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I have fluid in my chest or abdomen causing significant breathing problems.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median overall survival (OS)

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Median time to progression (TTP)

Objective response rate (ORR)

+1 more

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

Headache

Abdominal distension

Insomnia

Arthralgia

Asthenia

Pain in extremity

Alopecia

Urine ketone body present

Blood alkaline phosphatase increased

Pulmonary embolism

Lymphopenia

Leukopenia

Blood bilirubin increased

Dyspepsia

Sepsis

Palmar-plantar erythrodysaesthesia syndrome

Hypertension

Urine leukocyte esterase positive

Abdominal pain upper

Gastrooesophageal reflux disease

Proteinuria

Rash

Flatulence

Chills

Dry mouth

Myalgia

Epistaxis

Muscle spasms

Pneumonia

pelvic fracture

Haematemesis

Disease progression

Pleural effusion

Confusional state

Mental status changes

malignant neoplasm progression

Large intestine perforation

Oesophagitis

Lung abscess

embolism

pancreatic carcinoma

fall

Death

Haemorrhage intranial

Atrial fibrillation

Colitis

Enterocutaneous fistula

Gastrointestinal haemorrhage

Upper gastrointestinal haemorrhage

Chest pain

somnolence

syncope

Febrile neutropenia

Acute kidney injury

Acute respiratory failure

Hypoxia

Pneumonia aspiration

Clostridium difficile colitis

Influenza

Perirectal abscess

Salmonella sepsis

Septic shock

hip fracture

deep vein thrombosis

haematoma

pelvic venous thrombosis

Cholangitis

Ischaemic cerebral infarction

Hyperglycaemia

subdural haematoma

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1600

0 / 29Eligibility criteria met