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Tyrosine Kinase Inhibitor

Cabozantinib + Radiation Therapy for Soft Tissue Sarcoma

Phase 1 & 2

Waitlist Available

Led By Lee Cranmer

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine =< 2.0 x ULN or calculated creatinine clearance >= 30 mL/min (>= 0.5 mL/sec) using the Cockcroft-Gault equation

Subjects whose bowel cannot be completely protected from radiation exposure due to primary tumor location (e.g., proximal lower extremity) will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a drug and radiation therapy combination to treat sarcoma of the extremities. The drug may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving the drug with radiation therapy may make the tumors smaller and reduce the amount of normal tissue that needs to be removed.

Who is the study for?

Adults with confirmed sarcomas of the extremities needing radiation and surgery can join. They must have measurable tumors, proper organ function, no recent serious illnesses or surgeries, not be pregnant or breastfeeding, and agree to contraception. Excluded are those who've had certain treatments for their cancer, have brain metastases or significant heart issues.Check my eligibility

What is being tested?

The trial is testing how well cabozantinib works alongside radiation therapy in treating limb sarcomas. It aims to find the best dose with manageable side effects and see if it can shrink tumors effectively before surgical removal.See study design

What are the potential side effects?

Cabozantinib may cause fatigue, high blood pressure, hand-foot skin reactions, gastrointestinal symptoms like diarrhea and nausea, weight loss, decreased appetite and possible liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My cancer's location means my bowel can be shielded during radiation.

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My platelet count is above 100,000 without recent transfusions.

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My white blood cell count is healthy without needing medication in the last month.

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I will not have unprotected sex with a pregnant woman or a woman who could become pregnant while in the study.

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I am 18 or older with a confirmed sarcoma diagnosis in my limbs or glutes, planning for radiation and surgery.

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I am fully active or can carry out light work.

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My doctors believe my tumor can be removed with surgery.

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My hemoglobin level is at least 9 g/dL without recent transfusions.

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I am a man or a woman not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Rate of relapse (Phase II)

Recommended phase 2 dose of cabozantinib S-malate (cabozantinib) (Phase I)

Secondary outcome measures

Incidence of adverse events

Pattern of and time to local versus (vs.) distant recurrences

Rate of pathologic response

+4 more

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%

Activated Partial Thromboplastin Time Prolonged

15%

Sore Throat

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

Generalized Muscle Weakness

Allergic Rhinitis

Creatinine Increased

Hyponatremia

Flank Pain

Bone Pain

Gastroesophageal Reflux Disease

Chest Pain - Cardiac

Vertigo

Neutrophil Count Decreased

Arthralgia

Syncope

Proteinuria

Pleural Effusion

Nasal Congestion

Pleuritic Pain

Hoarseness

Nail Discoloration

Ventricular Tachycardia

Tinnitus

Gastrointestinal Pain

Floaters

Dysphagia

Blood Bilirubin Increased

Lung Infection

Fever

Depression

Hypersomnia

Hypotension

Productive Cough

Memory Impairment

Anxiety

Cardiac Troponin I Increased

Urinary Incontinence

Pancreatitis

Upper Respiratory Infection

Bruising

Weight Gain

Skin Induration

100%

80%

60%

40%

20%

Study treatment Arm

Cabozantinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cabozantinib S-malate, radiation therapy)Experimental Treatment2 Interventions

Patients receive cabozantinib S-malate PO QD on days 1-21. Cycles repeat every 21 days until the completion of radiation therapy in the absence of disease progression or unacceptable toxicity. Beginning cycle 1 day 8, patients also undergo standard of care radiation therapy for 5-6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib S-malate

2013

Completed Phase 2

~470

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,760 Total Patients Enrolled

ExelixisIndustry Sponsor

117 Previous Clinical Trials

19,545 Total Patients Enrolled

Lee CranmerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

3 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04220229 — Phase 1 & 2

Soft Tissue Sarcoma Research Study Groups: Treatment (cabozantinib S-malate, radiation therapy)

Soft Tissue Sarcoma Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT04220229 — Phase 1 & 2

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04220229 — Phase 1 & 2

Frequently Asked Questions

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

Does this clinical trial represent a groundbreaking new approach?

"Since 2012, Cabozantinib S-malate has been the subject of research. Originally sponsored by Exelixis and tested on 86 patients, it passed Phase 2 approval in the same year. Nowadays, 110 studies are being performed globally with 1315 cities and 45 countries providing data for this medication's efficacy."

Answered by AI

Has Cabozantinib S-malate been subjected to any other clinical trials in the past?

"Currently, 110 trials are researching cabozantinib s-malate with 12 of those in the late stages. Cordoba and Calabria both have ongoing studies for this medication. On a global scale, there are 6858 locations conducting research into its effects."

Answered by AI

What is the enrollment cap for this research project?

"Indeed, the trial can be found on clinicaltrials.gov and is actively accepting participants since its inception on June 1st 2020. Last updated August 2nd 2022, it seeks 46 volunteers from one medical centre."

Answered by AI

Are there still opportunities for individuals to join this clinical trial?

"According to the clinicaltrials.gov database, this medical study is recruiting participants. It was posted on June 1st 2020, and recently updated on August 2nd 2022."

Answered by AI

What medical conditions is Cabozantinib S-malate commonly utilized to treat?

"Cabozantinib S-malate can be an effective therapy for those who have had prior anti-vegf treatments, as well as patients suffering from advanced renal cell carcinoma and adrenal medulla."

Answered by AI

Recent research and studies

Pediatric Blood & CancerJournal

Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges

Vatner, Ralph, Charles D. James, Vythialingam Sathiaseelan, Kathryn M. Bondra, John A. Kalapurakal, and Peter J. Houghton. 2020. “Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.28439.

Pediatric Blood & CancerJournal

Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges

clinicaltrials.govStudy

Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities

2020. "Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04220229.