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Proteasome Inhibitor

Marizomib for Brain Cancer (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%
Insomnia
12%
Platelet Count Decreased
10%
Diarrhoea
10%
Thrombocytopenia
10%
Dizziness
10%
Radiation Skin Injury
9%
Asthenia
9%
Dysgeusia
8%
Weight Decreased
8%
Confusional State
7%
Muscular Weakness
7%
Aphasia
6%
Lymphopenia
6%
Hemiparesis
6%
Memory Impairment
6%
Anaemia
6%
Anxiety
6%
Lymphocyte Count Decreased
5%
Dyspnoea
5%
Gait Disturbance
5%
Depression
5%
Neutrophil Count Decreased
5%
Fall
5%
Cough
4%
Vision Blurred
4%
General Physical Health Deterioration
4%
Neutropenia
4%
Pyrexia
4%
Brain Oedema
4%
Tremor
4%
Weight Increased
4%
White Blood Cell Count Decreased
4%
Alanine Aminotransferase Increased
4%
Cognitive Disorder
4%
Dysarthria
4%
Pruritus
4%
Back Pain
3%
Balance Disorder
3%
Hypertension
3%
Dry Skin
3%
Urinary Tract Infection
3%
Myalgia
3%
Oedema Peripheral
3%
Arthralgia
3%
Dyspepsia
3%
Dermatitis
2%
Face Oedema
2%
Blood Creatinine Increased
2%
Abdominal Pain
2%
Pain In Extremity
2%
Disturbance In Attention
2%
Epilepsy
2%
Malaise
2%
Abdominal Pain Upper
2%
Influenza Like Illness
2%
Apraxia
2%
Erythema
2%
Hypokalaemia
2%
Oral Candidiasis
2%
Hyperglycaemia
2%
Cushingoid
2%
Malignant Neoplasm Progression
2%
Upper Respiratory Tract Infection
2%
Syncope
2%
Hypoaesthesia
2%
Herpes Zoster
2%
Gastrooesophageal Reflux Disease
2%
Tinnitus
2%
Leukopenia
2%
Paraesthesia
2%
Partial Seizures
1%
Contusion
1%
Hydrocephalus
1%
Agitation
1%
Pain
1%
Eye Pain
1%
Pneumonia
1%
Hypomagnesaemia
1%
Restlessness
1%
Vertigo
1%
Gingival Pain
1%
Scar Inflammation
1%
Conjunctivitis Viral
1%
Intracranial Pressure Increased
1%
Epistaxis
1%
Fungal Infection
1%
Delirium
1%
Osteoarthritis
1%
Anosmia
1%
Hemianopia
1%
Haematuria
1%
Deafness
1%
Ocular Hyperaemia
1%
Haemorrhoids
1%
Gamma-Glutamyltransferase Increased
1%
Hypotension
1%
Influenza
1%
Vitreous Floaters
1%
Discomfort
1%
Oedema
1%
Cellulitis
1%
Conjunctivitis
1%
Cystitis
1%
Pneumonitis
1%
Hot Flush
1%
Dry Mouth
1%
Facial Paresis
1%
Urinary Incontinence
1%
Palpitations
1%
Diplopia
1%
Flatulence
1%
Dyskinesia
1%
Skin Laceration
1%
Photophobia
1%
Flank Pain
1%
Neurological Decompensation
1%
Disorientation
1%
Thrombosis
1%
Pulmonary Embolism
1%
Scar Pain
1%
Ear Pain
1%
Radiation Alopecia
1%
Visual Impairment
1%
Dysphagia
1%
Gastroenteritis
1%
Depressed Level Of Consciousness
1%
Taste Disorder
1%
Polyuria
1%
Rash Maculo-Papular
1%
Cataract
1%
Oropharyngeal Pain
1%
Myopathy
1%
Glucose Tolerance Impaired
1%
Odynophagia
1%
Muscle Spasms
1%
Nasopharyngitis
1%
Amnesia
1%
Nasal Congestion
1%
Stomatitis
1%
Vasogenic Cerebral Oedema
1%
Gastrointestinal Pain
1%
Oral Herpes
1%
Ataxia
1%
Abdominal Distension
1%
Candida Infection
1%
Toothache
1%
Herpes Simplex Reactivation
1%
Motor Dysfunction
1%
Pain Of Skin
1%
Petechiae
1%
Haematoma
1%
Sinus Tachycardia
1%
Blood Cholesterol Increased
1%
Generalised Tonic-Clonic Seizure
1%
Nervous System Disorder
1%
Abulia
1%
Dysphonia
1%
Sinus Congestion
1%
Lacrimation Increased
1%
Bronchitis
1%
Dermatitis Contact
1%
Aspartate Aminotransferase Increased
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
164,932 Total Patients Enrolled
CelgeneIndustry Sponsor
645 Previous Clinical Trials
129,708 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
69,118 Total Patients Enrolled
~102 spots leftby Dec 2025
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