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Tyrosine Kinase Inhibitor

Radium-223 + Cabozantinib for Kidney Cancer with Bone Metastasis

Phase 2

Recruiting

Led By Rana R McKay

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

No concomitant anticoagulation with specified agents

No prior hemibody external radiotherapy or therapy with radium-223 dichloride or systemic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying whether adding radium-223 to cabozantinib improves outcomes for patients with renal cell cancer that has spread to the bone.

Who is the study for?

This trial is for adults with advanced kidney cancer that has spread to the bones. Participants must be in stable condition, have a certain level of physical ability (Karnofsky score >= 60%), and not have had major surgery or certain cancer treatments recently. They should not be pregnant or nursing, and those with brain metastases must be stable post-treatment.Check my eligibility

What is being tested?

The study is testing if adding radium-223 dichloride to cabozantinib improves outcomes for bone-spread kidney cancer. Radium-223 targets radiation at cancer cells while cabozantinib blocks enzymes needed for cell growth. The goal is to reduce pain and symptoms more effectively than with cabozantinib alone.See study design

What are the potential side effects?

Potential side effects include harm to normal cells leading to nausea, diarrhea, fatigue, blood count changes increasing infection risk or bleeding problems, and possible damage where bones are affected by the tumor.

Eligibility Criteria

Inclusion Criteria

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

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I am not taking certain blood thinners.

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I have not had certain types of radiation therapy.

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I have at least one cancer spread to bone that hasn't been treated with radiation.

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I am required to use bone-strengthening therapy unless it's harmful to me.

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I do not have a broken bone or pressure on my spinal cord due to cancer.

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I can care for myself but may need occasional help.

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I have been diagnosed with renal cell cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Symptomatic skeletal event (SSE)-free survival (FS)

Secondary outcome measures

Incidence of adverse events

Overall response rate (ORR)

Overall survival

+3 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (radium Ra 223 dichloride, cabozantinib s-malate)Experimental Treatment4 Interventions

Patients receive radium Ra 223 dichloride IV over 1 minute on day 1 of cycles 1-6 and cabozantinib S-malate PO QD on days 1-28 of every cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm B (cabozantinib s-malate)Active Control3 Interventions

Patients receive cabozantinib S-malate PO QD 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

Radium Ra 223 Dichloride

2017

Completed Phase 2

~90

Cabozantinib S-malate

2013

Completed Phase 2

~470

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,644 Total Patients Enrolled

Rana R McKayPrincipal InvestigatorAlliance for Clinical Trials in Oncology

1 Previous Clinical Trials

133 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04071223 — Phase 2

Kidney Cancer Research Study Groups: Arm A (radium Ra 223 dichloride, cabozantinib s-malate), Arm B (cabozantinib s-malate)

Kidney Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04071223 — Phase 2

Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04071223 — Phase 2

Frequently Asked Questions

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

Does this experimental procedure offer a fresh approach to treatment?

"At present, there are 109 functioning trials of Cabozantinib S-malate being conducted in 1315 cities spread across 45 nations. The first phase was initiated by Exelixis and observed 86 patients in 2012; since then, a total of 287 studies have been done."

Answered by AI

How many individuals can the study accommodate in total?

"To satisfy the requirements of this medical trial, 210 participants must meet all pre-existing eligibility criteria. Those who qualify can opt to partake in UPMC-Shadyside Hospital located in Pittsburgh, Pennsylvania or University of Kansas Cancer Center-Overland Park based out of Overland Park, Kansas."

Answered by AI

Could you share the potential dangers associated with utilizing Cabozantinib S-malate?

"Cabozantinib S-malate is believed to be somewhat safe, as evidenced by its 2 rating. This assessment was given due to the lack of available clinical efficacy data relative to safety findings in Phase 2 trials."

Answered by AI

What conditions is Cabozantinib S-malate typically deployed to treat?

"Patients with a history of anti-VEGF therapy, advanced renal cell carcinoma (ARCC), and adrenal medulla tumors can benefit from Cabozantinib S-malate treatment."

Answered by AI

Is recruitment for this trial ongoing?

"Affirmative. According to clinicaltrials.gov, this trial is looking for participants as it was first released on December 13th 2019 and updated lastly on November 24th 2022. 210 patients are required at 32 medical centres."

Answered by AI

How many medical institutions are currently evaluating this treatment?

"At present, 32 clinical trial sites are available to participate. These include Pittsburgh, Overland Park and Saint Peters, among other cities and towns. To reduce travel expenses, it is best to investigate the closest medical centre offering this opportunity."

Answered by AI

Have there been any previous analyses that have employed Cabozantinib S-malate?

"Cabozantinib S-malate was initially investigated in 2012 at Memorial Sloan Kettering Commack, and since then 287 trials have been concluded. Moreover, 109 studies are now actively running with a key concentration of research situated around Pittsburgh, Pennsylvania."

Answered by AI

Recent research and studies

Molecular OncologyJournal

Development and Initial Clinical Testing of a Multiplexed Circulating Tumor Cell Assay in Patients with Clear Cell Renal Cell Carcinoma

Bade, Rory M., Jennifer L. Schehr, Hamid Emamekhoo, Benjamin K. Gibbs, Tamara S. Rodems, Matthew C. Mannino, Joshua A. Desotelle, et al.. 2021. “Development and Initial Clinical Testing of a Multiplexed Circulating Tumor Cell Assay in Patients with Clear Cell Renal Cell Carcinoma”. Molecular Oncology. Wiley. doi:10.1002/1878-0261.12931.

clinicaltrials.govStudy

Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, the RadiCaL Study

2020. "Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, the RadiCaL Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04071223.

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