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Proteasome Inhibitor

Marizomib for Glioblastoma (MIRAGE Trial)

Phase 3
Waitlist Available
Led By Patrick Roth
Research Sponsored by European Organisation for Research and Treatment of Cancer - EORTC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until progression, assessed up to 49 months
Awards & highlights

Summary

This trial is testing a new drug called Marizomib added to the usual treatment for patients with newly diagnosed glioblastoma. The usual treatment includes chemotherapy and radiation. Marizomib works by blocking proteins that help cancer cells grow, making them more likely to die. The goal is to see if this combination improves survival rates.

Eligible Conditions
  • Glioblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until progression, assessed up to 49 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until progression, assessed up to 49 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
Health-related Quality of Life (HRQol)
Mini Mental State Examination (MMSE)
Progression Free Survival (PFS)

Side effects data

From 2023 Phase 3 trial • 749 Patients • NCT03345095
57%
Fatigue
41%
Nausea
33%
Constipation
33%
Alopecia
31%
Headache
18%
Vomiting
18%
Decreased Appetite
13%
Seizure
12%
Insomnia
12%
Platelet Count Decreased
10%
Radiation Skin Injury
10%
Dizziness
10%
Thrombocytopenia
10%
Diarrhoea
9%
Asthenia
9%
Dysgeusia
8%
Weight Decreased
8%
Confusional State
7%
Muscular Weakness
7%
Aphasia
6%
Anaemia
6%
Lymphopenia
6%
Anxiety
6%
Hemiparesis
6%
Memory Impairment
6%
Lymphocyte Count Decreased
5%
Fall
5%
Depression
5%
Cough
5%
Dyspnoea
5%
Gait Disturbance
5%
Neutrophil Count Decreased
4%
Brain Oedema
4%
Neutropenia
4%
Alanine Aminotransferase Increased
4%
Vision Blurred
4%
Tremor
4%
Cognitive Disorder
4%
Dysarthria
4%
Pruritus
4%
General Physical Health Deterioration
4%
Pyrexia
4%
Weight Increased
4%
White Blood Cell Count Decreased
4%
Back Pain
3%
Balance Disorder
3%
Arthralgia
3%
Dry Skin
3%
Dermatitis
3%
Hypertension
3%
Dyspepsia
3%
Oedema Peripheral
3%
Urinary Tract Infection
3%
Myalgia
2%
Abdominal Pain Upper
2%
Influenza Like Illness
2%
Pain In Extremity
2%
Leukopenia
2%
Hypokalaemia
2%
Epilepsy
2%
Hyperglycaemia
2%
Abdominal Pain
2%
Tinnitus
2%
Gastrooesophageal Reflux Disease
2%
Syncope
2%
Disturbance In Attention
2%
Hypoaesthesia
2%
Paraesthesia
2%
Partial Seizures
2%
Erythema
2%
Malignant Neoplasm Progression
2%
Cushingoid
2%
Face Oedema
2%
Malaise
2%
Herpes Zoster
2%
Oral Candidiasis
2%
Upper Respiratory Tract Infection
2%
Blood Creatinine Increased
2%
Apraxia
1%
Fungal Infection
1%
Nervous System Disorder
1%
Dermatitis Contact
1%
Visual Impairment
1%
Haematuria
1%
Gamma-Glutamyltransferase Increased
1%
Pneumonitis
1%
Disorientation
1%
Vitreous Floaters
1%
Contusion
1%
Urinary Incontinence
1%
Oropharyngeal Pain
1%
Petechiae
1%
Bronchitis
1%
Radiation Alopecia
1%
Osteoarthritis
1%
Facial Paresis
1%
Rash Maculo-Papular
1%
Oedema
1%
Aspartate Aminotransferase Increased
1%
Photophobia
1%
Cystitis
1%
Scar Pain
1%
Ear Pain
1%
Flatulence
1%
Gingival Pain
1%
Gastroenteritis
1%
Pneumonia
1%
Generalised Tonic-Clonic Seizure
1%
Pain Of Skin
1%
Thrombosis
1%
Glucose Tolerance Impaired
1%
Odynophagia
1%
Muscle Spasms
1%
Hydrocephalus
1%
Abdominal Distension
1%
Stomatitis
1%
Pulmonary Embolism
1%
Vertigo
1%
Eye Pain
1%
Gastrointestinal Pain
1%
Haemorrhoids
1%
Toothache
1%
Myopathy
1%
Ataxia
1%
Intracranial Pressure Increased
1%
Motor Dysfunction
1%
Neurological Decompensation
1%
Taste Disorder
1%
Abulia
1%
Agitation
1%
Nasal Congestion
1%
Complex Regional Pain Syndrome
1%
Depressed Level Of Consciousness
1%
Dizziness Postural
1%
Dyskinesia
1%
Hemianopia
1%
Lethargy
1%
Peripheral Sensory Neuropathy
1%
Somnolence
1%
Speech Disorder
1%
Vasogenic Cerebral Oedema
1%
Bradyphrenia
1%
Delirium
1%
Irritability
1%
Restlessness
1%
Nephrolithiasis
1%
Nocturia
1%
Pollakiuria
1%
Polyuria
1%
Dysphonia
1%
Epistaxis
1%
Sinus Congestion
1%
Acne
1%
Dermatitis Acneiform
1%
Dermatitis Allergic
1%
Psoriasis
1%
Rash
1%
Deep Vein Thrombosis
1%
Haematoma
1%
Hot Flush
1%
Hypotension
1%
Palpitations
1%
Sinus Tachycardia
1%
Deafness
1%
Cataract
1%
Diplopia
1%
Lacrimation Increased
1%
Ocular Hyperaemia
1%
Dry Mouth
1%
Dysphagia
1%
Chills
1%
Discomfort
1%
Pain
1%
Scar Inflammation
1%
Candida Infection
1%
Cellulitis
1%
Conjunctivitis
1%
Conjunctivitis Viral
1%
Herpes Simplex Reactivation
1%
Influenza
1%
Nasopharyngitis
1%
Oral Herpes
1%
Skin Laceration
1%
Blood Cholesterol Increased
1%
Hypomagnesaemia
1%
Flank Pain
1%
Musculoskeletal Pain
1%
Amnesia
1%
Anosmia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Arm
Experimental Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment3 Interventions
Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib
Group II: Standard ArmActive Control2 Interventions
Radiotherapy + Temozolomide followed by adjuvant Temozolomide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Marizomib
Not yet FDA approved
Temozolomide
FDA approved
radiotherapy
2007
Completed Phase 4
~3210

Find a Location

Who is running the clinical trial?

European Organisation for Research and Treatment of Cancer - EORTCLead Sponsor
414 Previous Clinical Trials
164,932 Total Patients Enrolled
20 Trials studying Glioblastoma
5,306 Patients Enrolled for Glioblastoma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
129,800 Total Patients Enrolled
10 Trials studying Glioblastoma
1,579 Patients Enrolled for Glioblastoma
Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
67,525 Total Patients Enrolled
2 Trials studying Glioblastoma
577 Patients Enrolled for Glioblastoma
~106 spots leftby Sep 2025