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Tyrosine Kinase Inhibitor

Cabozantinib for Childhood Cancer

Phase 2
Recruiting
Led By Nilay Shah, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgeries or trauma: Patients must not have had major surgical procedures within 4 weeks
Patient Body Surface Area (BSA): Patients must be ≥0.35 m2 in BSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-8 years
Awards & highlights

Summary

This trial will study whether the use of cabozantinib can prevent or slow the recurrent formation of pediatric solid tumors.

Who is the study for?
This trial is for children and young adults (18 months to under 40 years) with high-risk pediatric solid tumors like sarcoma or neuroblastoma, especially if they're at risk of recurrence. Participants need good organ function, no recent surgeries or biopsies, and must be able to swallow tablets. They should not be pregnant and must use contraception.
What is being tested?
The study tests Cabozantinib as a maintenance therapy in patients with minimal disease burden from specific pediatric cancers. It aims to prevent or delay tumor regrowth after initial treatment success, potentially extending disease control or achieving long-term cure.
What are the potential side effects?
Cabozantinib may cause side effects such as tiredness, digestive issues like diarrhea, mouth sores, hand-foot skin reactions, high blood pressure and can affect liver enzymes. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any major surgeries in the last 4 weeks.
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My body surface area is at least 0.35 square meters.
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My liver is functioning well.
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I am between 18 months and 40 years old.
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I can do most activities but may need help.
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I haven't had lung surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the effect of oral daily cabozantinib, administered for up to 12 months, on the one-year progression-free survival of patients with "ultra-high-risk" pediatric solid tumors.
Secondary study objectives
To evaluate the duration of response to cabozantinib, both during drug administration and after discontinuation of cabozantinib at study-defined time points.
To evaluate the effect of oral daily cabozantinib on the one-, two-, and five-year overall survival of patients with "ultra-high-risk" pediatric solid tumors.
To evaluate the effect of oral daily cabozantinib on the two- and five-year progression- free survival of patients with "ultra-high-risk" pediatric solid tumors.
+1 more

Side effects data

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
Enrolled patients will be treated with cabozantinib maleate, tablet formulation, using the recommended Phase 2 dose of 40 mg/m2/day, to a maximum of 420 mg/week. Treatment will be administered in 28- day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760

Find a Location

Who is running the clinical trial?

ExelixisIndustry Sponsor
119 Previous Clinical Trials
19,833 Total Patients Enrolled
3 Trials studying Sarcoma
141 Patients Enrolled for Sarcoma
Nationwide Children's HospitalLead Sponsor
347 Previous Clinical Trials
5,229,140 Total Patients Enrolled
1 Trials studying Sarcoma
50 Patients Enrolled for Sarcoma
Nilay Shah, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05135975 — Phase 2
Sarcoma Research Study Groups: Cabozantinib
Sarcoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05135975 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135975 — Phase 2
~22 spots leftby Jul 2025
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