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Tyrosine Kinase Inhibitor

Cabozantinib for Plexiform Neurofibroma (NF105-CABO Trial)

Phase 2
Waitlist Available
Led By Chie-Schin Shih, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 months
Awards & highlights

NF105-CABO Trial Summary

This trial is a Phase II, multicenter, open-label study of cabozantinib (XL184) in subjects

Eligible Conditions
  • Plexiform Neurofibromas
  • Neurofibromatosis

NF105-CABO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 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
The Change in Tumor Size Based on Radiographic Assessment
Secondary outcome measures
Number of Participants With Adverse Events

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
DIZZINESS
14%
BILIRUBIN INCREASED
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
RASH
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
SINUS BRADYCARDIA
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Hoarseness
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Stomach Pain
5%
TENDONITIS
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

NF105-CABO Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental Agent XL184 (Cabozantinib)Experimental Treatment1 Intervention
Cohort A (≥ 16 years - closed to accrual): Starting cabozantinib of 40 mg daily by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 60 mg based on dose tolerability. Subjects who do not tolerate 40 mg will dose reduce to 20 mg. Doses will be capped at 60 mg. Cohort B (3 - 15 years). The starting cabozantinib dose is 30 mg/m2/day by mouth per cycle. Duration of each cycle is 28 days. Subjects will dose escalate after 2 cycles to 40 mg/m2/day based on dose tolerability. Subjects who do not tolerate 30 mg/m2/day will dose reduce to 23 mg/m2/day. Doses will be capped at 60 mg/day max daily dose Each cohort will enroll up to 24 evaluable subjects with a target minimum of 17 evaluable subjects per cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,999 Total Patients Enrolled
Chie-Schin Shih, MDPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
19 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are part of this clinical trial?

"Unfortunately, this study is not presently enrolling patients. Although, it was originally posted on 6/1/2014 and last updated on 9/12/2022. However, there are 58 clinical trials actively recruiting patients with neurofibromatosis and 116 studies for Cabozantinib looking for participants."

Answered by AI

Are there any slots still available for volunteers in this experiment?

"This particular clinical trial is no longer recruiting patients. It was originally posted on June 1st, 2014 and last updated September 12th, 2022. If you're looking for other trials, there are currently 58 studies searching for patients with neurofibromatosis and 116 studies enrolling participants for Cabozantinib."

Answered by AI

Has this research been done before?

"Cabozantinib has been under medical scrutiny since 2012, when the first study was sponsored by Exelixis. This initial study had 86 participants. Following its completion, Cabozantinib received Phase 2 drug approval and there are now 116 live studies involving 1375 cities and 46 countries."

Answered by AI

Are there any previous examples of Cabozantinib's effects?

"Memorial Sloan Kettering Commack first studied cabozantinib in 2012 and, as of now, 55 clinical trials have been completed. 116 studies are currently active with many taking place near Bethesda, Maryland."

Answered by AI

Are there any negative side-effects to taking Cabozantinib?

"Cabozantinib received a score of 2 for safety. This is due to the fact that, while there is some data supporting its safety from Phase 2 clinical trials, there is no evidence indicating that it is an effective treatment."

Answered by AI

At how many distinct sites is this research being conducted?

"To reduce the burden of travel for participants, this trial is being conducted at 12 sites which are situated near large cities including Bethesda, Washington and Los Angeles. However, patients should select the location nearest to them to further limit travel."

Answered by AI

What conditions does Cabozantinib help alleviate?

"Patients that have undergone anti-vegf treatment in the past often respond well to Cabozantinib. Additionally, this medication can be used to treat other conditions such as advanced renal cell carcinoma (arcc), adrenal medulla, and high risk patients."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Nature MedicineJournal
Cabozantinib for Neurofibromatosis Type 1–related Plexiform Neurofibromas: A Phase 2 Trial
Fisher, Michael J., Neurofibromatosis Clinical Trials Consortium, Chie-Schin Shih, Steven D. Rhodes, Amy E. Armstrong, Pamela L. Wolters, Eva Dombi, et al.. 2021. “Cabozantinib for Neurofibromatosis Type 1–related Plexiform Neurofibromas: A Phase 2 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-01193-6.
The Lancet Child & Adolescent HealthJournal
Neurofibromatosis Type 1-related Tumours in Paediatrics: An Evolving Treatment Landscape
Armstrong, Amy E, Nicole M Brossier, and Angela C Hirbe. 2020. “Neurofibromatosis Type 1-related Tumours in Paediatrics: An Evolving Treatment Landscape”. The Lancet Child & Adolescent Health. Elsevier BV. doi:10.1016/s2352-4642(20)30169-3.
clinicaltrials.govStudy
Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults
Bruce Korf, MD 2014. "Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 in Children and Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02101736.
~4 spots leftby Apr 2025
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