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Cabozantinib S-malate for Alveolar Soft Part Sarcoma
Study 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.
- Alveolar Soft Part Sarcoma
- Osteosarcoma
- Brain Tumor
- Soft Tissue Sarcoma
- Primary Central Nervous System Neoplasm
- Rhabdomyosarcoma
- Clear Cell Sarcoma of Soft Tissue
- Liver Cancer
- Solid Tumors
- Hepatoblastoma
- Hepatocellular Carcinoma
- Ewing Sarcoma
- Kidney Cancer
- Adrenal Cortex Carcinoma
- Thyroid Carcinoma
- Adrenal Cancer
- Brain Cancer
- Wilms Tumor
- Malignant Brain Tumor
- Renal Cell Carcinoma
- Soft Tissue Sarcomas
- Tumors
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT02315430Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are any Canadian health facilities conducting this clinical experiment?
"Alliance for Childhood Diseases/Cure 4 the Kids Foundation in Las Vegas, Nevada, Children's Hospital of San Antonio in San Antonio, Texas and Summerlin Hospital Medical Center in Baltimore Maryland are some of the several clinical trial sites participating. Altogether there are 100 locations hosting this medical research project."
Does this clinical trial cater to participants aged 25 and younger?
"As outlined by the study's entry requirements, only patients aged between 2 and 30 can be considered for enrollment."
Are there prior investigations involving Cabozantinib S-malate?
"Currently, there are 11 phase 3 clinical trials for Cabozantinib S-malate and 109 overall. Of those studies, many of them take place in Cordoba or Calabria; however, the drug is being tested at 6849 distinct sites across the globe."
What conditions is Cabozantinib S-malate typically prescribed to treat?
"Cabozantinib S-malate may be a viable treatment option for those with prior anti-vegf treatments, advanced renal cell carcinoma (ARCC), and adrenal medulla."
What is the participant cap for this research study?
"Unfortunately, this research trial has now concluded. It began accepting participants on May 8th 2017 and was last updated on November 2nd 2022. If you are interested in other trials for osteosarcoma, there are currently 6225 studies enrolling patients; likewise, 109 clinical trials have open vacancies for individuals taking cabozantinib s-malate."
Is this trial actively seeking additional participants?
"This trial is not currently searching for participants. Initially posted on May 8th 2017 and edited most recently on November 2nd 2022, it has since been removed from active recruitment status. If you are looking to join a different clinical study, there are 6225 trials enrolling patients with osteosarcoma and 109 studies actively seeking candidates for Cabozantinib S-malate interventions."
Has the Food and Drug Administration accepted Cabozantinib S-malate for market authorization?
"Cabozantinib S-malate is thought to fall under the safety umbrella, so it was allocated a rating of 2. This score takes into consideration that while there is some evidence for its security, no data has been sourced which provides proof of efficacy."
Is this experiment an inaugural attempt at exploring a new therapeutic approach?
"Currently, 109 Cabozantinib S-malate trials are active worldwide across 45 countries and 1315 cities. The first such study began in 2012 with sponsorship from Exelixis involving 86 participants which successfully completed Phase 2 clinical approval. Since then, 226 studies have been conducted overall."
What is the primary goal of this research endeavor?
"This medical trial primarily aims to evaluate Objective Response (Non-Osteosarcoma Strata) over the course of 6 therapy cycles. Secondary outcomes include assessing the mean and standard deviation of Cabozantinib S-malate's Day 1 PK area under the curve, estimating Progression Free Survival using Kaplan-Meier methodology, and determining how many participants experience grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy within 30 days following their last dose."
Is it feasible for me to join this trial?
"This medical trial is attempting to recruit 109 candidates aged 2-30 with a diagnosis of osteosarcoma. Additionally, the upper age limit for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) must be =< 18 years old while all other diagnoses are capped at 30. Furthermore, participants must have an body surface area of no less than 0.35 m^2 in order to qualify."
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