← Back to Search

Tyrosine Kinase Inhibitor

Cabozantinib S-malate for Alveolar Soft Part Sarcoma

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
Wilms tumor Rare tumors
Osteosarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

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.

Eligible Conditions
  • 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 below
Select...
You have a rare cancer called Wilms tumor.
Select...
You have osteosarcoma.
Select...
You have Ewing sarcoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response (Non-Osteosarcoma Strata)
Objective Response (Osteosarcoma Stratum)
Secondary outcome measures
Overall Survival (OS)
Percentage of Participants With Adverse Events
Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC
+6 more
Other outcome measures
Change in Immune Biomarkers

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02315430
85%
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%
Generalized Muscle Weakness
8%
Allergic Rhinitis
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

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
~1080
Cabozantinib S-malate
2013
Completed Phase 2
~470

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,615 Previous Clinical Trials
40,918,588 Total Patients Enrolled
Srivandana AkshintalaPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~14 spots leftby Mar 2025