Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients With Advanced NEuroendocrine Tumors After Progression on Prior Therapy (CABINET)

Who is this study for? Patients with advanced pancreatic neuroendocrine and carcinoid tumors
What treatments are being studied? Cabozantinib S-malate
Status: Active_not_recruiting
Location: See all (434) locations...
Intervention Type: Other, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Documentation of Disease:

‣ Histologic Documentation: Well- or moderately-differentiated neuroendocrine tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local pathology

• The pathology report must state ONE of the following: 1) well- or moderately-differentiated neuroendocrine tumor, 2) low- or intermediate-grade neuroendocrine tumor, or 3) carcinoid tumor or atypical carcinoid tumor; documentation of histology from a primary or metastatic site is allowed

∙ Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma without specification of differentiation status, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible. Patients with well-differentiated grade 3 neuroendocrine tumor are eligible

⁃ Stage: Locally advanced/unresectable or metastatic disease

⁃ Tumor Site: Histological documentation of neuroendocrine tumor of pancreatic, gastrointestinal (GI), lung, thymus, other, or unknown primary site; GI, lung, thymus, other, and unknown primary NETs will enroll in the carcinoid tumor cohort of the study

• Functional (i.e., associated with symptoms or clinical syndrome related to hormone secretion by tumor) or nonfunctional tumors are allowed

⁃ Radiologic Evaluation: Target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in the 12 months prior to registration; the radiologic images, imaging reports, and clinic notes indicating growth of existing lesions, development of new lesions, or treatment changes must be submitted

• Measurable Disease

‣ Patients must have measurable disease per RECIST 1.1 by computer tomography (CT) scan or magnetic resonance imaging (MRI)

⁃ Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 1 cm with CT or MRI (or \>= 1.5 cm for lymph nodes); non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung

• Prior Treatment

‣ Patient must have experienced disease progression after receiving or intolerance leading to treatment discontinuation of at least one Food and Drug Administration (FDA)-approved line of therapy (except somatostatin analogs); prior lines of therapy must include one of the following: everolimus, sunitinib, or lutetium Lu 177 dotatate in patients with pancreatic NET; everolimus in patients with lung NET; everolimus or lutetium Lu 177 dotatate in patients with gastrointestinal NET

⁃ Prior treatment (except somatostatin analogs) with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, and/or radiation must be completed at least 28 days prior to registration

⁃ Prior treatment with somatostatin analogs is allowed, and continuation of treatment with somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months

⁃ Prior systemic treatment with radionuclide therapy must be completed at least 6 weeks prior to registration

⁃ Prior treatment with hepatic artery embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or if there is documented disease progression in a treated site; prior liver-directed or other ablative treatment must be completed at least 28 days prior to registration

⁃ Prior treatment with cabozantinib is not allowed

⁃ Patients should have resolution of any toxic effects of prior therapy (except alopecia and fatigue) to National Cancer Institute (NCI) CTCAE, version 5.0, grade 1 or less

⁃ Patients must have completed any major surgery at least 12 weeks prior to registration and any minor surgery (including uncomplicated tooth extractions) at least 28 days prior to registration; complete wound healing from major surgery must have occurred at least 28 days prior to registration, and complete wound healing from minor surgery must have occurred at least 10 days prior to registration

• Patient History

‣ No class III or IV congestive heart failure (CHF) within 6 months of registration

⁃ No clinically significant cardiac arrhythmia within 6 months of registration

⁃ No unstable angina or myocardial infarction (MI) within 6 months of registration

⁃ No thromboembolic events within 6 months of registration (including \[incl.\] stroke, transient ischemic attack \[TIA\], deep vein thrombosis \[DVT\], \& pulmonary embolism \[PE\])

⁃ No known history of congenital long QT syndrome

⁃ No uncontrolled hypertension within 14 days of registration (defined as systolic blood pressure \[SBP\] \>= 150 mmHg and/or diastolic blood pressure \[DBP\] \>= 90 mmHg despite optimal medical management)

⁃ No clinically significant GI bleeding within 6 months of registration

⁃ No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation

⁃ No GI perforation within 6 months of registration

⁃ No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration

⁃ No radiologic or clinical evidence of pancreatitis

⁃ No known cavitary lung lesions

⁃ No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; (CT with contrast is recommended to evaluate such lesions)

⁃ No hemoptysis greater than 1/2 teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration

⁃ No known tumor invading or encasing any major blood vessels

⁃ No history of non-healing wounds or ulcers within 28 days of registration

⁃ No history of fracture within 28 days of registration

⁃ No brain metastases or cranial epidural disease unless adequately treated, stable, and off steroid support for at least 4 weeks prior to registration

⁃ No known medical condition causing an inability to swallow oral formulations of agents

⁃ No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib/placebo

⁃ No currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ; patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for \>= 3 years

• Concomitant Medications

‣ Other planned concurrent investigational agents or other tumor directed therapies (chemotherapy, radiation) are not allowed while on this study

⁃ Concurrent use of somatostatin analogs while on cabozantinib/placebo is allowed provided that the patient has been on a stable dose for at least two months

⁃ Full dose oral anticoagulation/antiplatelet therapy is not permitted; low dose aspirin =\< 81 mg/day is allowed; anticoagulation with therapeutic doses of low molecular weight heparin (LMWH) is allowed in patients who are on a stable dose of LMWH for at least 6 weeks prior to registration; treatment with warfarin is not allowed; anticoagulation in patients with brain metastases is not permitted

⁃ Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed; patients must discontinue the drug at least 14 days prior to registration on the study

⁃ Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug at least 14 days prior to registration on the study

• Not pregnant and not nursing

‣ Women of childbearing potential must have a negative pregnancy test done =\< 14 days prior to registration

⁃ 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)

• Age \>= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2

• Absolute neutrophil count (ANC) \>= 1,500/mm\^3

• Hemoglobin \>= 9 g/dL

• Platelet count \>= 100,000/mm\^3

• Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin time (PTT) \< 1.3 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =\< 3 x ULN

• Total bilirubin =\< 1.5 x ULN

‣ Except in the case of Gilbert disease, in which case total bilirubin must be =\< 3 x ULN

• Creatinine =\< 1.5 mg/dL OR creatinine clearance \>= 45 mL/min

• Albumin \>= 2.8 g/dL

• Potassium within normal limits (WNL)

‣ Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal thyroid stimulating hormone (TSH), if free T4 is normal and patient is clinically euthyroid, patient is eligible

• Phosphorus WNL

‣ Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible

• Calcium WNL

‣ Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible

• Magnesium WNL

‣ Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible

• Urine protein to creatinine (UPC) ratio =\< 1

• QT interval corrected for heart rate using Fridericia's formula (QTcF) =\< 500 msec

• TSH WNL

‣ Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible

Locations
United States
Alaska
Katmai Oncology Group
Anchorage
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Kingman Regional Medical Center
Kingman
Mayo Clinic Hospital in Arizona
Phoenix
Banner University Medical Center - Tucson
Tucson
University of Arizona Cancer Center-North Campus
Tucson
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
PCR Oncology
Arroyo Grande
Sutter Auburn Faith Hospital
Auburn
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Mills-Peninsula Medical Center
Burlingame
City of Hope Comprehensive Cancer Center
Duarte
Epic Care-Dublin
Dublin
Epic Care Partners in Cancer Care
Emeryville
Kaiser Permanente-Fremont
Fremont
Palo Alto Medical Foundation-Fremont
Fremont
Kaiser Permanente-Fresno
Fresno
Contra Costa Regional Medical Center
Martinez
Fremont - Rideout Cancer Center
Marysville
Kaiser Permanente-Modesto
Modesto
Memorial Medical Center
Modesto
Palo Alto Medical Foundation-Camino Division
Mountain View
Alta Bates Summit Medical Center - Summit Campus
Oakland
Kaiser Permanente-Oakland
Oakland
Palo Alto Medical Foundation Health Care
Palo Alto
Stanford Cancer Institute Palo Alto
Palo Alto
Kaiser Permanente-Redwood City
Redwood City
Kaiser Permanente-Richmond
Richmond
Kaiser Permanente-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
Kaiser Permanente Downtown Commons
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Salinas Valley Memorial
Salinas
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Francisco
San Francisco
UCSF Medical Center-Mission Bay
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Mills Health Center
San Mateo
Kaiser Permanente-San Rafael
San Rafael
Kaiser San Rafael-Gallinas
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Kaiser Permanente-Santa Rosa
Santa Rosa
Kaiser Permanente-South San Francisco
South San Francisco
Kaiser Permanente-Stockton
Stockton
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Kaiser Permanente Medical Center-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Sutter Solano Medical Center/Cancer Center
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
Rocky Mountain Cancer Centers-Boulder
Boulder
Penrose-Saint Francis Healthcare
Colorado Springs
National Jewish Health-Main Campus
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Saint Joseph Hospital - Cancer Centers of Colorado
Denver
Mountain Blue Cancer Care Center - Swedish
Englewood
Swedish Medical Center
Englewood
National Jewish Health-Western Hematology Oncology
Golden
Saint Mary's Hospital and Regional Medical Center
Grand Junction
Banner North Colorado Medical Center
Greeley
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Banner North Colorado Medical Center - Loveland Campus
Loveland
National Jewish Health-Northern Hematology Oncology
Thornton
Intermountain Health Lutheran Hospital
Wheat Ridge
Connecticut
Danbury Hospital
Danbury
Norwalk Hospital
Norwalk
Washington, D.c.
MedStar Georgetown University Hospital
Washington D.c.
Florida
GenesisCare USA - Aventura
Aventura
GenesisCare USA - Aventura FP
Aventura
GenesisCare USA - Boca Ration FP06
Boca Raton
Regional Cancer Center-Lee Memorial Health System
Fort Myers
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood
Mayo Clinic in Florida
Jacksonville
Moffitt Cancer Center
Tampa
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Kaiser Permanente Moanalua Medical Center
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
Iowa
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf
Mercy Hospital
Cedar Rapids
Oncology Associates at Mercy Medical Center
Cedar Rapids
Mercy Cancer Center-West Lakes
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive
Heartland Oncology and Hematology LLP
Council Bluffs
Methodist Jennie Edmundson Hospital
Council Bluffs
Greater Regional Medical Center
Creston
Broadlawns Medical Center
Des Moines
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Cancer Institute - Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Kootenai Health - Coeur d'Alene
Coeur D'alene
Walter Knox Memorial Hospital
Emmett
Saint Luke's Cancer Institute - Fruitland
Fruitland
Idaho Urologic Institute-Meridian
Meridian
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Alphonsus Cancer Care Center-Nampa
Nampa
Saint Luke's Cancer Institute - Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Illinois CancerCare-Carthage
Carthage
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Carle at The Riverfront
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Illinois CancerCare-Dixon
Dixon
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Loyola University Medical Center
Maywood
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Cancer Care Center of O'Fallon
O'fallon
University of Chicago Medicine-Orland Park
Orland Park
Illinois CancerCare-Ottawa Clinic
Ottawa
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Illinois CancerCare-Peru
Peru
Illinois CancerCare-Princeton
Princeton
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Carle Cancer Center
Urbana
Illinois CancerCare - Washington
Washington
Indiana
Memorial Hospital of South Bend
South Bend
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Louisiana
Louisiana Hematology Oncology Associates LLC
Baton Rouge
LSU Health Baton Rouge-North Clinic
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
Our Lady of The Lake
Baton Rouge
Our Lady of the Lake Physician Group
Baton Rouge
Northshore Oncology Associates-Covington
Covington
Oncology Center of The South Incorporated
Houma
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Boston Medical Center
Boston
Brigham and Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Lahey Hospital and Medical Center
Burlington
Michigan
Hickman Cancer Center
Adrian
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Bronson Battle Creek
Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton
Trinity Health Medical Center - Brighton
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton
Trinity Health Medical Center - Canton
Canton
Caro Cancer Center
Caro
Chelsea Hospital
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea
Hematology Oncology Consultants-Clarkston
Clarkston
McLaren Cancer Institute-Clarkston
Clarkston
Newland Medical Associates-Clarkston
Clarkston
Henry Ford Health Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Henry Ford River District Hospital
East China Township
Weisberg Cancer Treatment Center
Farmington Hills
Cancer Hematology Centers - Flint
Flint
Genesee Hematology Oncology PC
Flint
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
McLaren Cancer Institute-Flint
Flint
Singh and Arora Hematology Oncology PC
Flint
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods
Beacon Kalamazoo Cancer Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing
University of Michigan Health - Sparrow Lansing
Lansing
Hope Cancer Clinic
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Henry Ford Saint John Hospital - Macomb Medical
Macomb
Henry Ford Warren Hospital - Breast Macomb
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette
Toledo Clinic Cancer Centers-Monroe
Monroe
McLaren Cancer Institute-Macomb
Mount Clemens
McLaren Cancer Institute-Central Michigan
Mount Pleasant
McLaren Cancer Institute-Northern Michigan
Petoskey
Hope Cancer Center
Pontiac
Michigan Healthcare Professionals Pontiac
Pontiac
Newland Medical Associates-Pontiac
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac
Huron Medical Center PC
Port Huron
Lake Huron Medical Center
Port Huron
McLaren-Port Huron
Port Huron
Henry Ford Rochester Hospital
Rochester Hills
MyMichigan Medical Center Saginaw
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights
MyMichigan Medical Center Tawas
Tawas City
Advanced Breast Care Center PLLC
Warren
Henry Ford Health Warren Hospital
Warren
Henry Ford Madison Heights Hospital - Breast
Warren
Henry Ford Warren Hospital - GLCMS
Warren
Macomb Hematology Oncology PC
Warren
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
Huron Gastroenterology PC
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Fairview Ridges Hospital
Burnsville
Minnesota Oncology - Burnsville
Burnsville
Mercy Hospital
Coon Rapids
Essentia Health - Deer River Clinic
Deer River
Essentia Health Cancer Center
Duluth
Fairview Southdale Hospital
Edina
Unity Hospital
Fridley
Essentia Health Hibbing Clinic
Hibbing
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
New Ulm Medical Center
New Ulm
North Memorial Medical Health Center
Robbinsdale
Mayo Clinic in Rochester
Rochester
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Essentia Health Sandstone
Sandstone
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Essentia Health Virginia Clinic
Virginia
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Fairview Lakes Medical Center
Wyoming
Missouri
Parkland Health Center-Bonne Terre
Bonne Terre
Saint Francis Medical Center
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
City Of Saint Peters
Siteman Cancer Center at West County Hospital
Creve Coeur
Parkland Health Center - Farmington
Farmington
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
Missouri Baptist Medical Center
St Louis
Siteman Cancer Center at Christian Hospital
St Louis
Siteman Cancer Center-South County
St Louis
Washington University School of Medicine
St Louis
Missouri Baptist Sullivan Hospital
Sullivan
BJC Outpatient Center at Sunset Hills
Sunset Hills
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Saint Vincent Frontier Cancer Center
Billings
Bozeman Health Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Logan Health Medical Center
Kalispell
Community Medical Center
Missoula
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Southeastern Medical Oncology Center-Clinton
Clinton
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Margaret R Pardee Memorial Hospital
Hendersonville
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
ECU Health Oncology Kinston
Kinston
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
Washington
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha
Nebraska Methodist Hospital
Omaha
Oncology Associates PC
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
Dartmouth Cancer Center - Nashua
Nashua
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Englewood Hospital and Medical Center
Englewood
Memorial Sloan Kettering Monmouth
Middletown
Memorial Sloan Kettering Bergen
Montvale
The Valley Hospital - Luckow Pavilion
Paramus
Valley Health System Ridgewood Campus
Ridgewood
Valley Medical Group - Wayne Multispecialty Practice
Wayne
New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque
Presbyterian Kaseman Hospital
Albuquerque
University of New Mexico Cancer Center
Albuquerque
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho
Nevada
Carson Tahoe Regional Medical Center
Carson City
Cancer and Blood Specialists-Henderson
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson
Las Vegas Cancer Center-Henderson
Henderson
Oncology Las Vegas - Henderson
Henderson
OptumCare Cancer Care at Seven Hills
Henderson
Ann M Wierman MD LTD
Las Vegas
Cancer and Blood Specialists-Shadow
Las Vegas
Cancer and Blood Specialists-Tenaya
Las Vegas
Cancer Therapy and Integrative Medicine
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
Desert West Surgery
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas
Hope Cancer Care of Nevada
Las Vegas
Las Vegas Cancer Center-Medical Center
Las Vegas
Oncology Las Vegas - Tenaya
Las Vegas
OptumCare Cancer Care at Charleston
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
OptumCare Cancer Care at MountainView
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
University Cancer Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
Hope Cancer Care of Nevada-Pahrump
Pahrump
Radiation Oncology Associates
Reno
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
Hematology Oncology Associates of Central New York-Auburn
Auburn
Roswell Park Cancer Institute
Buffalo
Hematology Oncology Associates of CNY at Camillus
Camillus
Memorial Sloan Kettering Commack
Commack
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse
Memorial Sloan Kettering Westchester
Harrison
Memorial Sloan Kettering Cancer Center
New York
Mount Sinai Hospital
New York
University of Rochester
Rochester
Memorial Sloan Kettering Nassau
Uniondale
Wilmot Cancer Institute at Webster
Webster
Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood
Strecker Cancer Center-Belpre
Belpre
Miami Valley Hospital South
Centerville
Adena Regional Medical Center
Chillicothe
Case Western Reserve University
Cleveland
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
The Mark H Zangmeister Center
Columbus
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Premier Blood and Cancer Center
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Atrium Medical Center-Middletown Regional Hospital
Franklin
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
OhioHealth Marion General Hospital
Marion
Toledo Clinic Cancer Centers-Maumee
Maumee
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights
Licking Memorial Hospital
Newark
University Hospitals Parma Medical Center
Parma
Mercy Health - Perrysburg Hospital
Perrysburg
Southern Ohio Medical Center
Portsmouth
Mercy Health - Saint Anne Hospital
Toledo
Toledo Clinic Cancer Centers-Toledo
Toledo
Upper Valley Medical Center
Troy
University Hospitals Sharon Health Center
Wadsworth
UH Seidman Cancer Center at Saint John Medical Center
Westlake
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Alphonsus Cancer Care Center-Baker City
Baker City
Providence Cancer Institute Clackamas Clinic
Clackamas
Providence Newberg Medical Center
Newberg
Saint Alphonsus Cancer Care Center-Ontario
Ontario
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Pocono Medical Center
East Stroudsburg
Saint Vincent Hospital
Erie
Lehigh Valley Hospital-Hazleton
Hazleton
Jefferson Hospital
Jefferson Hills
Forbes Hospital
Monroeville
Fox Chase Cancer Center
Philadelphia
Temple University Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Allegheny General Hospital
Pittsburgh
West Penn Hospital
Pittsburgh
Wexford Health and Wellness Pavilion
Wexford
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Prisma Health Cancer Institute - Easley
Easley
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Utah
Farmington Health Center
Farmington
Huntsman Cancer Institute/University of Utah
Salt Lake City
University of Utah Sugarhouse Health Center
Salt Lake City
Washington
Virginia Mason Medical Center
Seattle
Wisconsin
ThedaCare Regional Cancer Center
Appleton
Duluth Clinic Ashland
Ashland
Marshfield Medical Center-EC Cancer Center
Eau Claire
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
Marshfield Medical Center-Marshfield
Marshfield
Marshfield Medical Center - Minocqua
Minocqua
ProHealth D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Marshfield Medical Center-Rice Lake
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Marshfield Medical Center - Weston
Weston
West Virginia
Edwards Comprehensive Cancer Center
Huntington
West Virginia University Healthcare
Morgantown
Wyoming
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Time Frame
Start Date: 2018-10-26
Completion Date: 2026-08-19
Participants
Target number of participants: 298
Treatments
Experimental: Arm I (cabozantinib S-malate)
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and urine sample collection, and CT, MRI, and/or x-ray imaging during screening and on study.
Placebo_comparator: Arm II (placebo)
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and urine sample collection, and CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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