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Cediranib Maleate for Glioblastoma

Phase 2
Waitlist Available
Led By Tracy T Batchelor
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to 6 months.
Awards & highlights

Study Summary

This study is evaluating whether temozolomide, radiation therapy, and cediranib maleate are more effective than temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma.

Eligible Conditions
  • Glioblastoma
  • Gliosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to time of death due to any cause. patients are followed until death. analysis occurs after all patients have been potentially followed for six months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to time of death due to any cause. patients are followed until death. analysis occurs after all patients have been potentially followed for six months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-month Progression-free Survival Rate
Secondary outcome measures
Incidence of Grade 3+ Toxicities
Overall Survival (OS)
Progression-free Survival (PFS)

Side effects data

From 2016 Phase 2 trial • 53 Patients • NCT01132820
81%
Fatigue
69%
Diarrhea
60%
Hypertension
48%
Anorexia
46%
Nausea
35%
Anemia
33%
Weight Loss
31%
Vomiting
31%
Peripheral Sensory Neuropathy
29%
Mucositis Oral
29%
Hypothyroidism
27%
Constipation
25%
Aspartate Aminotransferase Increased
23%
Headache
23%
Abdominal Pain
23%
Platelet Count Decreased
23%
Creatinine Increased
23%
White Blood Cell Decreased
21%
Urinary Tract Infection
21%
Pain
21%
Hyponatremia
21%
Proteinuria
19%
Alanine Aminotransferase Increased
19%
Hypomagnesemia
19%
Hypoalbuminemia
19%
Hypokalemia
17%
Dry Mouth
17%
Hyperglycemia
15%
Dyspnea
15%
Alkaline Phosphatase Increased
15%
Hypocalcemia
13%
Myalgia
10%
Dizziness
10%
Dehydration
10%
Voice Alteration
10%
Oral Pain
8%
Palmar-Plantar Erythrodysesthesia Syndrome
8%
Hoarseness
8%
Neoplasms Benign, Malignant And Unspecified (Incl
8%
Arthralgia
8%
Dyspepsia
8%
Neutrophil Count Decreased
8%
Back Pain
8%
Anxiety
6%
Dry Skin
6%
Blurred Vision
6%
Thromboembolic Event
6%
Cough
6%
Generalized Muscle Weakness
6%
Hypoglycemia
6%
Insomnia
6%
Tinnitus
6%
Fever
6%
Bruising
4%
Upper Respiratory Infection
4%
Flatulence
4%
Epistaxis
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Dysgeusia
4%
Alopecia
4%
Abdominal Distension
4%
Fecal Incontinence
4%
Rash Maculo-Papular
4%
Bladder Infection
4%
Dry Eye
4%
Rectal Hemorrhage
4%
Gastroesophageal Reflux Disease
4%
Edema Limbs
4%
Inr Increased
4%
Activated Partial Thromboplastin Time Prolonged
4%
Hypophosphatemia
4%
Hypernatremia
4%
Hyperkalemia
4%
Pelvic Pain
4%
Cognitive Disturbance
2%
Muscle Weakness Lower Limb
2%
Acute Kidney Injury
2%
Blood Bilirubin Increased
2%
Cholesterol High
2%
Gallbladder Pain
2%
Hemoglobin Increased
2%
Edema Face
2%
Gait Disturbance
2%
Nasal Congestion
2%
Acidosis
2%
Vaginal Hemorrhage
2%
Breast Pain
2%
Chest Wall Pain
2%
Blood And Lymphatic System Disorders - Other
2%
Rectal Pain
2%
Lymphocyte Count Decreased
2%
Hypotension
2%
Bullous Dermatitis
2%
Urinary Tract Obstruction
2%
Pain In Extremity
2%
Multi-Organ Failure
2%
Pruritus
2%
Esophageal Pain
2%
Pleuritic Pain
2%
Gastric Hemorrhage
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Middle Ear Inflammation
2%
Ascites
2%
General Disorders And Administration Site Conditio
2%
Allergic Rhinitis
2%
Oral Hemorrhage
2%
Peripheral Motor Neuropathy
2%
Colitis
2%
Anal Hemorrhage
2%
Oral Dysesthesia
2%
Gastrointestinal Pain
2%
Joint Range Of Motion Decreased
2%
Hematuria
2%
Vaginal Pain
2%
Confusion
2%
Death Nos
2%
Myocardial Infarction
2%
Colonic Perforation
2%
Rectal Fistula
2%
Ileal Obstruction
2%
Peritoneal Necrosis
2%
Lung Infection
2%
Chest Pain - Cardiac
2%
Sinus Tachycardia
2%
Sinus Bradycardia
2%
Vertigo
2%
Conjunctivitis
2%
Endocrine Disorders - Other
2%
Eye Disorders - Other
2%
Hyperthyroidism
2%
Dysphagia
2%
Gastric Ulcer
2%
Flu Like Symptoms
2%
Skin Infection
2%
Investigations - Other
2%
Chills
2%
Lipase Increased
2%
Syncope
2%
Neck Pain
2%
Flank Pain
2%
Intracranial Hemorrhage
2%
Memory Impairment
2%
Vaginal Dryness
2%
Depressed Level Of Consciousness
2%
Depression
2%
Skin Induration
2%
Urinary Tract Pain
2%
Respiratory Failure
2%
Hot Flashes
2%
Hematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cediranib

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cediranib, TMZ, and RTExperimental Treatment5 Interventions
Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum.
Group II: Placebo, TMZ, and RTActive Control5 Interventions
Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Temozolomide
2010
Completed Phase 3
~1930
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Cediranib Maleate
2010
Completed Phase 2
~660

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,406 Total Patients Enrolled
322 Trials studying Glioblastoma
22,854 Patients Enrolled for Glioblastoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,591 Total Patients Enrolled
13 Trials studying Glioblastoma
3,867 Patients Enrolled for Glioblastoma
Radiation Therapy Oncology GroupNETWORK
190 Previous Clinical Trials
64,666 Total Patients Enrolled
19 Trials studying Glioblastoma
6,729 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma
2010. "Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01062425.
~17 spots leftby Apr 2025
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