- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04071223
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
A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To assess the symptomatic skeletal event (SSE)-free survival of metastatic renal cell cancer (mRCC) patients with bone metastases treated with cabozantinib S-malate (cabozantinib) + radium Ra 223 dichloride (radium-223 dichloride) compared to cabozantinib alone.
SECONDARY OBJECTIVES:
I. To investigate the safety, toxicity and tolerability as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in patients treated with cabozantinib + radium-223 dichloride compared to cabozantinib alone.
II. To assess SSE-free survival of each treatment arm in predefined sub-groups. III. To assess progression-free survival (PFS) in each treatment arm. IV. To assess overall survival (OS) in each treatment arm. V. To assess time to first SSE (defined as first use of radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or symptomatic tumor-related orthopaedic surgical intervention) in each treatment arm.
VI. To assess the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
VII. To assess time to subsequent anti-cancer systemic therapy and type of systemic therapy.
EXPLORATORY QUALITY OF LIFE OBJECTIVES:
I. To compare patient-reported pain as assessed by the Brief Pain Inventory questionnaire (BPI) between patients randomized to cabozantinib versus cabozantinib + radium-223 dichloride at 6 months.
II. To compare patient-reported pain as assessed by the BPI between patients randomized to cabozantinib versus cabozantinib + radium-223 dichloride at other timepoints.
III. To compare overall health-related quality of life as assessed by the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Global Health 10 between patients randomized to cabozantinib versus cabozantinib + radium-223 dichloride.
IV. To compare quality-adjusted survival (overall survival x utility score assessed by European Quality of Life Five Dimension Five Level Scale [EQ5D-5L]) between patients randomized to cabozantinib + radium-223 dichloride.
CORRELATIVE OBJECTIVES:
I. To evaluate changes in the following bone turnover markers between arms:
Ia. Marker of bone formation: P1NP, BSAP. Ib. Marker of bone resorption: CTX, NTX. II. To correlate changes in bone turnover markers with SSE-free survival. III. To assess the immunomodulatory properties of cabozantinib with or without radium-223 dichloride at baseline, during treatment, and at progression.
IV. To identify prognostic and predictive genomic biomarkers of response to cabozantinib and radium-223 dichloride via assessment of tissue, circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic acid (DNA) (cfDNA).
V. To assess the association between bone response according to MD Anderson response criteria and SSE-free survival (FS).
VI. To correlate change in level of total alkaline phosphatase and bone-specific alkaline phosphatase to overall response to cabozantinib + radium-223 dichloride compared to cabozantinib alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive radium Ra 223 dichloride intravenously (IV) over 1 minute on day 1 of cycles 1-6 and cabozantinib S-malate orally (PO) once daily (QD) on days 1-28 of every cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B: 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.
After completion of study treatment, patients are followed up every 6 months for up to 5 years from study registration.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Active, not recruiting
- University of Alabama at Birmingham Cancer Center
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California
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La Jolla, California, United States, 92093
- Recruiting
- UC San Diego Moores Cancer Center
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Contact:
- Site Public Contact
- Phone Number: 858-822-5354
- Email: cancercto@ucsd.edu
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Principal Investigator:
- Rana R. McKay
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Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
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Contact:
- Site Public Contact
- Phone Number: 916-734-3089
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Principal Investigator:
- Mamta Parikh
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- Rush University Medical Center
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Contact:
- Site Public Contact
- Phone Number: 312-942-5498
- Email: clinical_trials@rush.edu
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Principal Investigator:
- Thomas C. Westbrook
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Comprehensive Cancer Center
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Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
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Principal Investigator:
- Walter M. Stadler
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Decatur, Illinois, United States, 62526
- Recruiting
- Cancer Care Specialists of Illinois - Decatur
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Principal Investigator:
- Bryan A. Faller
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Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
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Maywood, Illinois, United States, 60153
- Suspended
- Loyola University Medical Center
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New Lenox, Illinois, United States, 60451
- Active, not recruiting
- UC Comprehensive Cancer Center at Silver Cross
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Orland Park, Illinois, United States, 60462
- Active, not recruiting
- University of Chicago Medicine-Orland Park
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Iowa
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Ankeny, Iowa, United States, 50023
- Recruiting
- Mission Cancer and Blood - Ankeny
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Principal Investigator:
- Joshua Lukenbill
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Contact:
- Site Public Contact
- Phone Number: 515-282-2921
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Des Moines, Iowa, United States, 50309
- Recruiting
- Medical Oncology and Hematology Associates-Des Moines
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Principal Investigator:
- Joshua Lukenbill
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Contact:
- Site Public Contact
- Phone Number: 515-241-3305
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Des Moines, Iowa, United States, 50309
- Recruiting
- Iowa Methodist Medical Center
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Principal Investigator:
- Joshua Lukenbill
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Contact:
- Site Public Contact
- Phone Number: 515-241-6727
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa/Holden Comprehensive Cancer Center
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Contact:
- Site Public Contact
- Phone Number: 800-237-1225
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Principal Investigator:
- Yousef Zakharia
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Cancer Center
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Contact:
- Site Public Contact
- Phone Number: 913-588-3671
- Email: KUCC_Navigation@kumc.edu
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Principal Investigator:
- Elizabeth M. Wulff-Burchfield
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Overland Park, Kansas, United States, 66210
- Suspended
- University of Kansas Cancer Center-Overland Park
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Westwood, Kansas, United States, 66205
- Recruiting
- University of Kansas Hospital-Westwood Cancer Center
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Contact:
- Site Public Contact
- Phone Number: 913-588-3671
- Email: KUCC_Navigation@kumc.edu
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Principal Investigator:
- Elizabeth M. Wulff-Burchfield
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Louisiana
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Metairie, Louisiana, United States, 70006
- Suspended
- East Jefferson General Hospital
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Metairie, Louisiana, United States, 70006
- Suspended
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University School of Medicine
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Principal Investigator:
- Mark Sides
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Contact:
- Site Public Contact
- Phone Number: 504-988-1147
- Email: bweimer1@tulane.edu
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
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Contact:
- Site Public Contact
- Phone Number: 877-442-3324
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Principal Investigator:
- Bradley A. McGregor
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Worcester, Massachusetts, United States, 01655
- Recruiting
- UMass Memorial Medical Center - University Campus
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Contact:
- Site Public Contact
- Phone Number: 508-856-3216
- Email: cancer.research@umassmed.edu
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Principal Investigator:
- Kriti Mittal
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Recruiting
- Saint Joseph Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
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Principal Investigator:
- Tareq Al Baghdadi
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Detroit, Michigan, United States, 48202
- Active, not recruiting
- Henry Ford Hospital
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Livonia, Michigan, United States, 48154
- Recruiting
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
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Principal Investigator:
- Tareq Al Baghdadi
-
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Minnesota
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Maplewood, Minnesota, United States, 55109
- Recruiting
- Minnesota Oncology Hematology PA-Maplewood
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
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Principal Investigator:
- Daniel M. Anderson
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Missouri
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Creve Coeur, Missouri, United States, 63141
- Recruiting
- Siteman Cancer Center at West County Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
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Kansas City, Missouri, United States, 64154
- Recruiting
- University of Kansas Cancer Center - North
-
Contact:
- Site Public Contact
- Phone Number: 913-588-3671
- Email: KUCC_Navigation@kumc.edu
-
Principal Investigator:
- Elizabeth M. Wulff-Burchfield
-
Lee's Summit, Missouri, United States, 64064
- Recruiting
- University of Kansas Cancer Center - Lee's Summit
-
Contact:
- Site Public Contact
- Phone Number: 913-588-3671
- Email: KUCC_Navigation@kumc.edu
-
Principal Investigator:
- Elizabeth M. Wulff-Burchfield
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
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Saint Louis, Missouri, United States, 63131
- Recruiting
- Missouri Baptist Medical Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 314-996-5569
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Saint Louis, Missouri, United States, 63129
- Recruiting
- Siteman Cancer Center-South County
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
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Saint Peters, Missouri, United States, 63376
- Recruiting
- Siteman Cancer Center at Saint Peters Hospital
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Principal Investigator:
- Hiram A. Gay
-
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New York
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New York, New York, United States, 10065
- Recruiting
- NYP/Weill Cornell Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 212-746-1848
-
Principal Investigator:
- Ana M. Molina
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-668-0683
- Email: cancerclinicaltrials@med.unc.edu
-
Principal Investigator:
- Tracy L. Rose
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Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 888-275-3853
-
Principal Investigator:
- Michael R. Harrison
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Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-293-5066
- Email: Jamesline@osumc.edu
-
Principal Investigator:
- Yuanquan Yang
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
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Principal Investigator:
- Tyler Gunter
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University of Pittsburgh Cancer Institute (UPCI)
-
Contact:
- Site Public Contact
- Phone Number: 412-647-8073
-
Principal Investigator:
- Ravi Patel
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC-Shadyside Hospital
-
Contact:
- Site Public Contact
- Phone Number: 412-621-2334
-
Principal Investigator:
- Ravi Patel
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Texas
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Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
Dallas, Texas, United States, 75237
- Recruiting
- UT Southwestern Simmons Cancer Center - RedBird
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
Fort Worth, Texas, United States, 76104
- Recruiting
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
Richardson, Texas, United States, 75080
- Recruiting
- UT Southwestern Clinical Center at Richardson/Plano
-
Contact:
- Site Public Contact
- Phone Number: 972-669-7044
- Email: Suzanne.cole@utsouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Principal Investigator:
- Umang Swami
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Site Public Contact
- Phone Number: 414-805-3666
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Principal Investigator:
- Deepak Kilari
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes of RCC are eligible including but not limited to clear cell, papillary, chromophobe, translocation, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Enrollment of non-clear cell patients will be limited to 20% of the total sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and rhabdoid differentiation are allowed
Presence of at least 1 metastatic bone lesion not treated with prior radiation is required.
- The presence of bone metastases can be detected by computed tomography (CT), magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging. Patients with non-measurable bone-only disease are allowed. Patients may have received prior radiation therapy for bone metastases or other external radiation >= 7 days prior to registration, as long as they still have at least 1 metastatic bone lesion not treated with radiation. Patients with visceral metastases are allowed, as long as they have at least one untreated bone metastases
- No prior treatment with cabozantinib
- No treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of registration or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of registration
- No prior hemibody external radiotherapy
- No prior therapy with radium-223 dichloride or systemic radiotherapy (such as samarium, strontium)
- No major surgery within 6 weeks of randomization. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye surgery are not considered major surgery. Patients who have had a nephrectomy may be registered >= 3 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
- Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy
The use of osteoclast targeted therapy including either bisphosphonates or denosumab is mandated on this study except in patients with contraindications as determined by the treating investigator, including:
- Hypocalcemia
- Hypophosphatemia
- Renal impairment including those with a glomerular filtration rate (GFR) < 35 mL/min using the Cockcroft-Gault equation or acute renal impairment
Hypersensitivity to drug formulation
- Dental condition or need for dental intervention that per the investigator would increase the risk of osteonecrosis of jaw (ONJ).
- Use of osteoclast targeted therapy or reason against use needs to be recorded in the electronic case report form (eCRF). Additionally, reason for discontinuation of osteoclast targeted therapy need to be appropriately documented in the eCRF
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
- Therefore, for women of childbearing potential only, a negative urine pregnancy test done =< 28 days prior to registration is required. A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Karnofsky performance status >= 60%
- No brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
- No imminent or established spinal cord compression based on clinical symptoms and/or imaging. In patients with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration
- No imminent or impending pathologic fracture based on clinical symptoms and/or imaging. In patients with untreated imminent or impending pathologic fracture, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration
No significant, uncontrolled intercurrent or recent illness, including but not limited to the following conditions:
- Cardiovascular disorders: Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia; uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment; stroke (including transient ischemic attack), myocardial infarction, or other ischemic event, within 6 months before randomization; thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization
- Gastrointestinal disorders: Disorders associated with a high risk of perforation or fistula formation: active inflammatory bowel disease, active diverticulitis, active cholecystitis, active symptomatic cholangitis or active appendicitis, active acute pancreatitis or active acute obstruction of the pancreatic or biliary duct, or active gastric outlet obstruction; abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 3 months before randomization. Note: Complete healing of an intra-abdominal abscess must be confirmed before randomization
- No clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before randomization
- No lesions invading major pulmonary blood vessels
No other clinically significant disorders:
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]) with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]), if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (with no medications prohibited by this protocol [e.g. drug-drug interactions])
- No serious non-healing wound or ulcer
- No malabsorption syndrome
- No uncompensated/symptomatic hypothyroidism
- No moderate to severe hepatic impairment (Child-Pugh B or C)
- No requirements for hemodialysis or peritoneal dialysis
- No history of solid organ transplantation
- No chronic concomitant treatment with strong CYP3A4 inducers or inhibitors. Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference. Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants include:
- Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dl (transfusions allowed)
- Calculated (calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
- Total bilirubin =< 1.5 x upper limit of normal (ULN), for patients with Gilberts disease =< 3.0 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
- Urine protein to creatinine (UPC) ratio =< 2 mg/mg OR 24-hr urine protein < 2 g
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (radium Ra 223 dichloride, cabozantinib s-malate)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Given IV
Other Names:
|
Active Comparator: Arm B (cabozantinib s-malate)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptomatic skeletal event (SSE)-free survival (FS)
Time Frame: From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years
|
SSE-FS distribution will be estimated using the method of Kaplan-Meier by treatment arm.
Comparison between the two arms will be performed using a one-sided log-rank test and one-sided p-value less than 0.025 will indicate that the experimental arm is superior to the control arm.
SSE-FS will be censored at the date of last SSE assessment for those alive and SSE free.
Hazard ratio (experimental over control arm) as well as two-sided 90% confidence interval (CI) for treatment will be estimated using the stratified Cox proportional hazard model with a single treatment covariate.
|
From the date of randomization to the date of the earliest occurrence of SSE or death from any cause, assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 5 years
|
Will be determined using Common Terminology Criteria for Adverse Events version 5.0.
Adverse events will be summarized and compared between arms using chi-square or fisher exact tests as appropriate.
|
Up to 5 years
|
SSE-FS
Time Frame: From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years
|
Will be estimated with the Kaplan Meier methodology.
Comparison between arms or between predefined groups will be conducted using the log-rank test.
|
From randomization to the date of SSE or death due to any cause, whichever comes first, assessed up to 5 years
|
Progression-free survival
Time Frame: From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years
|
Radiographic progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Will be estimated with the Kaplan Meier methodology.
Comparison between arms or between predefined groups will be conducted using the log-rank test.
|
From randomization to time of radiographic progression or death due to any cause, whichever occurs first, assessed up to 5 years
|
Overall survival
Time Frame: From randomization to the date of death due to any cause, assessed up to 5 years
|
Will be estimated with the Kaplan Meier methodology.
Comparison between arms or between predefined groups will be conducted using the log-rank test.
Patients who are alive will be censored at last follow up date.
|
From randomization to the date of death due to any cause, assessed up to 5 years
|
Time to first SSE
Time Frame: From randomization to the date of first SSE or death due to any cause, assessed up to 5 years
|
Will be determined in each treatment.
The median estimate to first SSE-FS will be calculated.
|
From randomization to the date of first SSE or death due to any cause, assessed up to 5 years
|
Overall response rate (ORR)
Time Frame: Up to 5 years
|
Will be defined by RECIST version 1.1.
Number and proportion of patients achieving ORR (by RECIST) will be summarized with two-sided 90% CI by treatment arm; comparison between arms will be conducted using chi-square or Fisher's exact test as appropriate.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rana R McKay, Alliance for Clinical Trials in Oncology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Neuroendocrine Tumors
- Carcinoma, Neuroendocrine
- Neoplasms, Ductal, Lobular, and Medullary
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Carcinoma, Medullary
- Antineoplastic Agents
- Radium Ra 223 dichloride
Other Study ID Numbers
- NCI-2019-05619 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180821 (U.S. NIH Grant/Contract)
- A031801 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Clear Cell Renal Cell Carcinoma
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Celldex TherapeuticsTerminatedKidney Neoplasms | Metastatic Renal Cell Carcinoma | Ovarian Clear Cell Carcinoma | Papillary Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) | Clear-cell Renal Cell CarcinomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
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Guru SonpavdePfizer; Hoosier Cancer Research NetworkWithdrawnKidney Cancer | Clear-cell Renal Cell Carcinoma | RCC | Clear-cell Kidney CarcinomaUnited States
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AmgenCompletedRenal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Clear Cell Renal Carcinoma | Renal Cell AdenocarcinomaFrance, United States, Germany
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University of WashingtonMerck Sharp & Dohme LLC; Prometheus LaboratoriesTerminatedMetastatic Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer | Advanced Clear Cell Renal Cell Carcinoma | Stage IV Renal Cell CancerUnited States
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Telix International Pty LtdGrand Pharmaceutical (China) Co., Ltd.CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Cancer | Suspected Recurrent Renal Clear Cell CarcinomaChina
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M.D. Anderson Cancer CenterActive, not recruitingMetastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8United States
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Peloton Therapeutics, Inc.Active, not recruitingA Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)Kidney Cancer | Clear Cell Renal Cell Carcinoma | Glioblastoma | Solid Tumor | Glioblastoma Multiforme | Advanced Solid Tumors | GBM | Solid Tumor, Adult | Solid Carcinoma | Glioblastoma, Adult | ccRCC | RCC, Clear Cell Adenocarcinoma | RCC | Renal Cell Carcinoma, Metastatic | Renal Cell Carcinoma Recurrent | Renal Cell...
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Queen Mary University of LondonAstraZeneca; Vall d'Hebron Institute of OncologyActive, not recruitingRenal Clear Cell Carcinoma | Renal Papillary Cell CarcinomaUnited Kingdom
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Association Pour La Recherche des Thérapeutiques...CompletedClear-cell Metastatic Renal Cell Carcinoma | Clear-cell Renal CarcinomaFrance
Clinical Trials on Quality-of-Life Assessment
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Malignant NeoplasmUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)RecruitingChildhood Malignant NeoplasmUnited States, Canada, Puerto Rico, Australia, New Zealand
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Wake Forest University Health SciencesWithdrawnLung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
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Sidney Kimmel Cancer Center at Thomas Jefferson...RecruitingGlioblastoma | WHO Grade III Glioma | WHO Grade II GliomaUnited States
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M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
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M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Breast Carcinoma | Head and Neck Carcinoma | Lung Carcinoma | Esophageal Carcinoma | Malignant Digestive System Neoplasm | Malignant Central Nervous System Neoplasm | Genitourinary System CarcinomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBreast Carcinoma | Cancer SurvivorUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedFallopian Tube Cancer | Recurrent Endometrial Carcinoma | Stage IV Ovarian Epithelial Cancer | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Recurrent Uterine Sarcoma | Stage III Uterine Sarcoma | Stage IV Uterine Sarcoma | Recurrent Ovarian Epithelial Cancer | Stage IV Endometrial Carcinoma | Ovarian... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Recruiting