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Proteasome Inhibitor

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed 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
Pivotal Trial
No Placebo-Only Group

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
  • Brain Cancer

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
164,861 Total Patients Enrolled
CelgeneIndustry Sponsor
645 Previous Clinical Trials
129,435 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
69,118 Total Patients Enrolled
Patrick RothPrincipal InvestigatorEORTC Study Coordinator
~101 spots leftby Jan 2026
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