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Tyrosine Kinase Inhibitor
Cabozantinib for Rare Cancers in Young Patients
Phase 2
Waitlist Available
Led By Srivandana Akshintala
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 younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trialstudies how well cabozantinib-s-malate works to treat rare tumors in younger patients, blocking enzymes needed for tumor growth and blood vessel growth.
Who is the study for?
This trial is for young patients up to 18 years old with specific rare tumors or sarcomas, including Wilms tumor, and some up to 30 years old. They must have measurable disease, adequate organ function, no prior treatment with MET/HGF inhibitors like XL184, and not be on certain medications that affect the liver or heart.
What is being tested?
The effectiveness of Cabozantinib-S-Malate is being tested in this phase II trial. It's aimed at treating children and young adults whose tumors are recurrent, resistant to therapy or newly diagnosed without known curative options.
What are the potential side effects?
Potential side effects include issues related to blocking enzymes needed for tumor growth which may affect normal cells too. This can lead to problems with blood pressure control, digestive system absorption, bleeding risks and possibly impact cardiac health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response (Non-Osteosarcoma Strata)
Objective Response (Osteosarcoma Stratum)
Secondary study objectives
Overall Survival (OS)
Percentage of Participants With Adverse Events
Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC
+6 moreOther study objectives
Change in Immune Biomarkers
Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Sore Throat
15%
Activated Partial Thromboplastin Time Prolonged
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Allergic Rhinitis
8%
Generalized Muscle Weakness
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
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 (cabozantinib s-malate)Experimental Treatment3 Interventions
Patients receive cabozantinib-s-malate orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~2360
Cabozantinib S-malate
2013
Completed Phase 2
~590
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,111,978 Total Patients Enrolled
Srivandana AkshintalaPrincipal InvestigatorChildren's Oncology Group