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Monoclonal Antibodies
Trebananib for Glioblastoma
Phase 2
Waitlist Available
Led By Eudocia Q Lee
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically proven diagnosis of glioblastoma or variants (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma); patients will be eligible if the original histology was a lower grade glioma and a subsequent histological diagnosis of glioblastoma or variants is made
The tumor must be supratentorial; patients with infratentorial disease, spinal cord disease, and/or leptomeningeal disease are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 3 years.
Awards & highlights
Study Summary
This trial is testing the side effects and effectiveness of bevacizumab with or without trebananib for brain tumors that have come back.
Eligible Conditions
- Glioblastoma
- Gliosarcoma
- Oligodendroglioma
- Brain Tumor
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 3 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1)
Six-month Progression-free Survival (Cohort 2)
Secondary outcome measures
Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)
Overall Survival (Cohort 2)
Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)
+2 moreOther outcome measures
Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2)
Side effects data
From 2016 Phase 2 trial • 35 Patients • NCT0121022269%
Fatigue
53%
Anemia
50%
Constipation
38%
Hypertension
38%
Nausea
31%
Edema Limbs
31%
Anorexia
31%
Peripheral Sensory Neuropathy
28%
Abdominal Pain
25%
Hyperglycemia
25%
Hyponatremia
25%
Diarrhea
25%
Hypoalbuminemia
25%
Cough
22%
Vomiting
22%
Dyspnea
22%
Alkaline Phosphatase Increased
19%
Anxiety
19%
Dyspepsia
19%
Back Pain
16%
Ascites
16%
Hypomagnesemia
16%
Hypokalemia
16%
Dizziness
16%
Hypocalcemia
16%
Pain In Extremity
13%
Thromboembolic Event
13%
Bloating
13%
Proteinuria
13%
Insomnia
13%
Depression
13%
Abdominal Distension
13%
Dehydration
9%
Hematuria
9%
Lymphedema
9%
Pain
9%
Localized Edema
9%
Creatinine Increased
9%
Urinary Frequency
9%
Hyperkalemia
9%
Headache
9%
Urinary Tract Pain
9%
Death Nos
9%
Weight Gain
9%
Platelet Count Decreased
9%
Inr Increased
6%
Ggt Increased
6%
Arthralgia
6%
Urinary Retention
6%
Pelvic Pain
6%
Pleural Effusion
6%
Nasal Congestion
6%
Palpitations
6%
Dysphagia
6%
Dry Mouth
6%
Mucositis Oral
6%
Gastroesophageal Reflux Disease
6%
Chills
6%
Urinary Tract Infection
6%
Fall
6%
Weight Loss
6%
Aspartate Aminotransferase Increased
6%
Activated Partial Thromboplastin Time Prolonged
6%
Generalized Muscle Weakness
3%
Flank Pain
3%
Phlebitis
3%
Irritability
3%
Alopecia
3%
Rash Maculo-Papular
3%
Lethargy
3%
Hot Flashes
3%
Edema Face
3%
Hemoglobin Increased
3%
White Blood Cell Decreased
3%
Hypophosphatemia
3%
Hypoglycemia
3%
Agitation
3%
Urinary Urgency
3%
Urinary Tract Obstruction
3%
Urinary Incontinence
3%
Acute Kidney Injury
3%
Vaginal Hemorrhage
3%
Vaginal Dryness
3%
Vaginal Discharge
3%
Voice Alteration
3%
Upper Gastrointestinal Hemorrhage
3%
Movements Involuntary
3%
Facial Muscle Weakness
3%
Dysgeusia
3%
Cognitive Disturbance
3%
Suicidal Ideation
3%
Hallucinations
3%
Sore Throat
3%
Pneumothorax
3%
Hoarseness
3%
Sinus Tachycardia
3%
Vertigo
3%
Tinnitus
3%
Hearing Impaired
3%
Eye Disorders - Other
3%
Watering Eyes
3%
Flashing Lights
3%
Blurred Vision
3%
Eyelid Function Disorder
3%
Ileus
3%
Oral Cavity Fistula
3%
Rectal Pain
3%
Esophagitis
3%
Flatulence
3%
Flu Like Symptoms
3%
Edema Trunk
3%
Fever
3%
Bronchial Infection
3%
Wrist Fracture
3%
Wound Complication
3%
Investigations - Other
3%
Lymphocyte Count Decreased
3%
Alanine Aminotransferase Increased
3%
Hypernatremia
3%
Hypermagnesemia
3%
Hypercalcemia
3%
Myalgia
3%
Chest Wall Pain
3%
Peripheral Motor Neuropathy
3%
Kidney Infection
3%
Seizure
3%
Colonic Obstruction
3%
Small Intestinal Obstruction
3%
Muscle Weakness Lower Limb
3%
Wheezing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Trebananib)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (bevacizumab and trebananib)Experimental Treatment4 Interventions
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (bevacizumab and placebo)Active Control4 Interventions
Patients receive bevacizumab as in Arm I and placebo IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over to Arm I.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Trebananib
2012
Completed Phase 2
~380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,621 Previous Clinical Trials
40,927,285 Total Patients Enrolled
315 Trials studying Glioblastoma
22,487 Patients Enrolled for Glioblastoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,715 Total Patients Enrolled
13 Trials studying Glioblastoma
3,991 Patients Enrolled for Glioblastoma
Eudocia Q LeePrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
114 Total Patients Enrolled
2 Trials studying Glioblastoma
114 Patients Enrolled for Glioblastoma
Frequently Asked Questions
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