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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

Must not have

Treatment with any anti-cancer therapy within 3 weeks of registration

Concomitant anticoagulation with specified agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't received any cancer treatment in the last 3 weeks.

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I am currently taking blood thinners.

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I do not have major health issues like HIV, severe liver problems, or need for dialysis.

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I cannot receive treatments that target bone breakdown.

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I have dental issues that could increase my risk of jawbone damage.

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My cancer has sarcomatoid or rhabdoid features.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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%

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

Allergic Rhinitis

Generalized Muscle Weakness

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (radium Ra 223 dichloride, cabozantinib s-malate)Experimental Treatment9 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. Patients undergo blood sample collection, bone scan, CT, or MRI, and may undergo FDG-PET or NaF-PET throughout the study.

Group II: Arm B (cabozantinib s-malate)Active Control8 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. Patients undergo blood sample collection, bone scan, CT, or MRI, and may undergo FDG-PET or NaF-PET throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Radium Ra 223 Dichloride

2017

Completed Phase 2

~90