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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib + Radiation + Temozolomide for Glioblastoma

Phase 1

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

Arm 1: Supratentorial unmethylated MGMT glioblastoma

Arm 1: Patient with any surgery more than stereotactic biopsy

Must not have

Use of specific anticoagulants

Serious concurrent infection or illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of combining ibrutinib with radiation at different dose levels in people with glioblastoma that has not been methylated.

Who is the study for?

This trial is for adults with newly diagnosed glioblastoma, specifically those with unmethylated MGMT tumors or methylated MGMT tumors. Participants must be in good physical condition (Karnofsky performance ≥ 70%), not pregnant, and willing to use birth control. They should have no serious concurrent illnesses, bleeding disorders, or recent surgeries and cannot be on certain medications that affect the immune system.

What is being tested?

The trial tests the safety of combining a drug called Ibrutinib with radiation therapy at different doses for patients with unmethylated MGMT glioblastoma. It also examines how well Ibrutinib works alongside Temozolomide (TMZ) and radiation in patients with methylated MGMT glioblastoma.

What are the potential side effects?

Possible side effects include increased risk of infection due to immune suppression, bleeding issues related to blood clotting problems, liver function changes, heart rhythm abnormalities, fatigue from anemia or other blood cell count changes, and potential allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of brain tumor that is above the cerebellum and lacks a certain DNA marker.

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I have had surgery beyond a simple biopsy.

Exclusion Criteria

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

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I am taking certain blood thinners.

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I do not have any serious infections or illnesses.

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I do not have an ongoing, untreated infection.

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I've had brain surgery, radiation, and TMZ treatment for my tumor.

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I have a serious liver condition.

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I am currently taking medication to suppress my immune system.

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I have not had major surgery in the last 4 weeks.

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I finished treatment for an infection less than 14 days ago.

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I have used ibrutinib or similar drugs before, or I am allergic to parts of the study drug.

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I am currently receiving treatment for my tumor.

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I have heart problems and abnormal heart test results.

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I am taking medication that affects liver enzyme levels.

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I have a known bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD) of ibrutinib

Secondary study objectives

Length of time of overall survival

Number of patients who experience adverse events

Number of patients with Progression Free Survival (PFS)

Side effects data

From 2022 Phase 3 trial • 201 Patients • NCT03053440

37%

Diarrhoea

32%

Upper respiratory tract infection

29%

Muscle spasms

28%

Contusion

24%

Arthralgia

24%

Hypertension

22%

Oedema peripheral

22%

Anaemia

21%

Epistaxis

20%

Cough

19%

Rash

19%

Fatigue

18%

Back pain

18%

Atrial fibrillation

17%

Urinary tract infection

16%

Neutropenia

16%

Thrombocytopenia

15%

Nausea

15%

Headache

15%

Vomiting

14%

Pneumonia

14%

Dizziness

13%

Haematuria

12%

Peripheral swelling

12%

Pyrexia

12%

Constipation

11%

Localised infection

10%

Pain in extremity

10%

Onychoclasis

10%

Fall

10%

Oropharyngeal pain

10%

Lower respiratory tract infection

10%

Sinusitis

10%

Palpitations

Insomnia

Nasopharyngitis

Hyperuricaemia

Dyspnoea

Haematoma

Skin laceration

Paraesthesia

Dyspepsia

Dry skin

Cellulitis

Conjunctivitis

Skin infection

Iron deficiency

Anxiety

Rhinitis

Cataract

Conjunctival haemorrhage

Pruritus

Hypokalaemia

Syncope

Vision blurred

Abdominal pain

Abdominal pain upper

Nail infection

Neck pain

Purpura

Asthenia

Abdominal discomfort

Chest pain

Gingival bleeding

Mouth ulceration

Stomatitis

Onychomycosis

Rhinorrhoea

Actinic keratosis

Dermatitis

Petechiae

Influenza like illness

COVID-19

Gastroenteritis

Tooth infection

Limb injury

Squamous cell carcinoma of skin

Peripheral sensory neuropathy

Rosacea

Increased tendency to bruise

Gout

Basal cell carcinoma

Folliculitis

Oral herpes

Gastrooesophageal reflux disease

Retinal haemorrhage

Angina pectoris

Dry mouth

Vertigo

Haemorrhoids

Ecchymosis

Sepsis

Chills

Bronchitis

Furuncle

Joint injury

Blood alkaline phosphatase increased

Neutrophil count decreased

Decreased appetite

Joint swelling

Depression

Productive cough

Skin ulcer

Atrial flutter

Hyperglycaemia

Herpes zoster

Abdominal distension

Tinnitus

Bladder transitional cell carcinoma

Rotator cuff syndrome

Sinus bradycardia

Inguinal hernia

Dysphagia

Dry eye

Dysuria

Pollakiuria

Hypoalbuminaemia

Osteoporosis

Erythema

Acute myocardial infarction

Malaise

Cystitis

Alanine aminotransferase increased

Gamma-glutamyltransferase increased

Musculoskeletal chest pain

Seborrhoeic keratosis

Neuralgia

Benign prostatic hyperplasia

Dyspnoea exertional

Nasal congestion

Pneumonitis

Psoriasis

Skin fissures

Skin lesion

Laryngitis

Respiratory tract infection

Bradycardia

Acute kidney injury

Wound infection

Myalgia

Skin toxicity

Ear infection

Paronychia

Osteoarthritis

Pericarditis

Sciatica

Ocular hyperaemia

Nail disorder

Pleural effusion

Rectal haemorrhage

Cholecystitis

COVID-19 pneumonia

Drug withdrawal syndrome

Seasonal allergy

Vitamin D deficiency

Rash maculo-papular

Hypotension

Death

Loss of consciousness

Post procedural haemorrhage

Laryngeal oedema

Stress fracture

Lumbar vertebral fracture

Haemolytic anaemia

Haemorrhagic disorder

Viral infection

Wound infection staphylococcal

Cardiac failure acute

Wheezing

Colitis

Oral blood blister

Upper gastrointestinal haemorrhage

Drug-induced liver injury

Bacterial sepsis

Brain abscess

Device related infection

Gastrointestinal infection

Neurocryptococcosis

Septic shock

Streptococcal bacteraemia

Femoral neck fracture

Femur fracture

Subdural haematoma

Lethargy

Subarachnoid haemorrhage

Chronic kidney disease

Urinary bladder haemorrhage

Prostatitis

Acute pulmonary oedema

Hyponatraemia

Muscular weakness

Rash erythematous

Hyperviscosity syndrome

Melaena

Clostridium difficile infection

Post procedural sepsis

Pyelonephritis

Cerebrovascular accident

Respiratory disorder

Lymphadenopathy

Streptococcal sepsis

Amyloidosis

Influenza

Pneumonia viral

Coronary artery disease

Pericardial haemorrhage

Urosepsis

Spinal stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Ibrutinib

Arm B: Zanubrutinib

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Unmethylated MGMT GlioblastomaExperimental Treatment2 Interventions

Every patient gets ibrutinib + radiation over 6 weeks. Patients will undergo a 4-week break and then Ibrutinib treatment will continue until disease progression, intolerable toxicity, or death.

Group II: Methylated MGMT GlioblastomaExperimental Treatment3 Interventions

Every patient gets ibrutinib + radiation + daily Temozolomide (TMZ) (75mg/m2) for 6 weeks. Patients will undergo a 4-week break and patients will then receive daily ibrutinib and adjuvant Temozolomide for Days 1-5 of a 28-day cycle of temozolomide for 6 cycles. The temozolomide will continue until disease progression, intolerable toxicity, or death or maximum of 6 cycles. Ibrutinib treatment will continue until disease progression, intolerable toxicity, or death.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide (TMZ)

2005

Completed Phase 3

~760

Radiation

2003

Completed Phase 2

~780