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Tyrosine Kinase Inhibitor
Treatment (cediranib maleate) for Neurofibromatosis
Phase 2
Waitlist Available
Led By Dusica Babovic-Vuksanovic
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 registration to death (due to any cause) max 51 months
Awards & highlights
No Placebo-Only Group
Summary
This phase II trial is studying how well AZD2171 works in treating patients with neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Eligible Conditions
- Spinal Cord Tumors
- Neurofibromatosis
- Plexiform Neurofibroma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration to death (due to any cause) max 51 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration to death (due to any cause) max 51 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])
Secondary study objectives
Duration of Response as Assessed Using the Method of Kaplan-Meier
Reduction in Self Reported Worst Pain Per Cycle.
Survival Time as Measured Using Kaplan-Meier Method
+2 moreSide effects data
From 2016 Phase 2 trial • 53 Patients • NCT0113282081%
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%
Dehydration
10%
Dizziness
10%
Voice Alteration
10%
Oral Pain
8%
Hoarseness
8%
Palmar-Plantar Erythrodysesthesia Syndrome
8%
Neoplasms Benign, Malignant And Unspecified (Incl
8%
Arthralgia
8%
Dyspepsia
8%
Neutrophil Count Decreased
8%
Back Pain
8%
Anxiety
6%
Generalized Muscle Weakness
6%
Dry Skin
6%
Cough
6%
Blurred Vision
6%
Hypoglycemia
6%
Thromboembolic Event
6%
Insomnia
6%
Tinnitus
6%
Fever
6%
Bruising
4%
Abdominal Distension
4%
Flatulence
4%
Rash Maculo-Papular
4%
Fecal Incontinence
4%
Alopecia
4%
Skin And Subcutaneous Tissue Disorders - Other
4%
Epistaxis
4%
Dysgeusia
4%
Upper Respiratory Infection
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%
Ascites
2%
Urinary Tract Obstruction
2%
Lymphocyte Count Decreased
2%
Pruritus
2%
General Disorders And Administration Site Conditio
2%
Gastric Hemorrhage
2%
Reversible Posterior Leukoencephalopathy Syndrome
2%
Vaginal Hemorrhage
2%
Pleuritic Pain
2%
Acute Kidney Injury
2%
Middle Ear Inflammation
2%
Hypotension
2%
Blood Bilirubin Increased
2%
Muscle Weakness Lower Limb
2%
Hemoglobin Increased
2%
Acidosis
2%
Breast Pain
2%
Nasal Congestion
2%
Allergic Rhinitis
2%
Cholesterol High
2%
Chest Wall Pain
2%
Multi-Organ Failure
2%
Blood And Lymphatic System Disorders - Other
2%
Rectal Pain
2%
Esophageal Pain
2%
Gallbladder Pain
2%
Pain In Extremity
2%
Edema Face
2%
Gait Disturbance
2%
Bullous Dermatitis
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cediranib maleate)Experimental Treatment1 Intervention
Patients receive oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to course 2, prior to course 4, and every 6 courses thereafter.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,024,348 Total Patients Enrolled
3 Trials studying Neurofibromatosis
290 Patients Enrolled for Neurofibromatosis
Dusica Babovic-VuksanovicPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
9 Total Patients Enrolled
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