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Tyrosine Kinase Inhibitor

Cabozantinib for Pediatric Cancers

Phase 1
Waitlist Available
Led By Meredith K Chuk
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 5 years
Awards & highlights

Study Summary

This trial studies the effects of a drug that could stop the growth of cancer cells in younger patients with advanced tumors. #Cancer

Who is the study for?
This trial is for young patients with solid tumors, including brain and thyroid cancers, that have returned or are treatment-resistant. Participants need a minimum body surface area (0.35 m^2 or 0.44 m^2 depending on the dose level), stable neurological conditions, recovery from prior chemotherapy effects, and no curative therapy options available. They must not be pregnant/breastfeeding, on certain medications like CYP3A4 inducers/inhibitors or QTc prolonging drugs, and should be able to swallow tablets.Check my eligibility
What is being tested?
The trial tests Cabozantinib S-malate's safety and optimal dosage in younger patients with recurrent/refractory solid tumors. It aims to find out if this drug can halt tumor growth by inhibiting specific enzymes needed for cell proliferation.See study design
What are the potential side effects?
Potential side effects of Cabozantinib S-malate include but are not limited to: fatigue, high blood pressure, hand-foot skin reactions (redness and peeling), gastrointestinal symptoms (diarrhea, nausea), weight loss due to decreased appetite, abnormal liver enzyme levels indicating potential liver issues.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearance of Cabozantinib S-malate
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib
Secondary outcome measures
Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184
Change From Baseline in VEGF-R2 Concentration
Disease Response of Cabozantinib S-malate
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib S-malate)Experimental Treatment3 Interventions
Patients receive cabozantinib S-malate PO QD on days 1-28. Courses 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
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,446 Total Patients Enrolled
Meredith K ChukPrincipal InvestigatorCOG Phase I Consortium

Frequently Asked Questions

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

Are participants aged 45 and above being considered for this research?

"The age boundaries for participation in this trial are 2 and 18, respectively; all patients below or above these ages will be ineligible."

Answered by AI

Has cabozantinib S-malate been tested in other scientific investigations?

"Cabozantinib S-malate was initially researched at the Massachusetts General Hospital back in 2011 and since then, 704 studies have been successfully completed. At present, 98 trials are still being conducted with a significant portion of them located within San Francisco."

Answered by AI

Is there an eligibility criteria for participating in this clinical experiment?

"Eligible subjects for this medical experiment must have a primary central nervous system neoplasm and be between the ages of 2-18. A total of 41 individuals are needed to fill out the trial."

Answered by AI

Is this an unprecedented research endeavor?

"Initially researched in 2011, cabozantinib S-malate has been granted Phase 2 drug approval following its first trial conducted by Exelixis. As of now, 98 trials are underway at 1382 sites within 46 countries worldwide."

Answered by AI

Is the utilization of cabozantinib S-malate in humans safe and reliable?

"Subsequently to our assessment, the safety of cabozantinib S-malate was rated a 1 due to this being an early Phase 1 trial and only limited data supporting efficacy or safety."

Answered by AI

In how many locations has this trial been established?

"This clinical trial is enrolling participants at UCSF Medical Center-Mission Bay in San Francisco, California; National Institutes of Health Clinical Center in Bethesda, Maryland; and Children's National Medical Center in Washington, District of Columbia. Additionally, the study has 25 other sites located throughout the United States."

Answered by AI

What medical conditions can cabozantinib S-malate be employed to address?

"Cabozantinib S-malate is typically given to people who have already been treated with anti-VEGF medications. Apart from that, it also has applications for advanced renal cell carcinoma (ARCC), adrenal medulla and high risk patients suffering from various conditions."

Answered by AI

What is the total capacity of participants in this experiment?

"At the current time, this particular medical study is not actively recruiting. It was first advertised on November 14th 2012 and last edited on September 26th 2023. However, there are 5899 other clinical trials looking for patients with primary central nervous system neoplasm and 98 studies involving cabozantinib S-malate that are welcoming participants."

Answered by AI

Are there any ongoing recruitment efforts for this experiment?

"Unfortunately, this trial has closed its recruitment period; initial posting was on November 14th 2012 and the last edit occurred September 26th 2023. For those seeking an alternative study, there are presently 5899 trials recruiting patients with primary central nervous system neoplasms and 98 different studies enrolling participants for cabozantinib S-malate treatment."

Answered by AI
~3 spots leftby Apr 2025