CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
NCT ID: NCT03428217
Last Updated: 2023-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
444 participants
INTERVENTIONAL
2018-04-24
2021-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pbo-Cabo
Placebo twice daily (BID) + cabozantinib (60 mg once daily \[QD\]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.
Cabozantinib
Oral receptor tyrosine kinase inhibitor
Placebo
Placebo tablets
CB-Cabo
CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.
CB-839
Oral glutaminase inhibitor
Cabozantinib
Oral receptor tyrosine kinase inhibitor
Interventions
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CB-839
Oral glutaminase inhibitor
Cabozantinib
Oral receptor tyrosine kinase inhibitor
Placebo
Placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult patients
3. Karnofsky Performance Score (KPS) ≥ 70%
4. Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
5. 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (RCC) including one anti-angiogenic therapy (any vascular endothelial growth factor \[VEGF\] pathway-targeted agent used either as monotherapy or as a component of a combination regimen) OR the combination regimen of nivolumab + ipilimumab
6. Adequate hepatic, renal, cardiac and hematologic function
Exclusion Criteria
2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
3. Untreated or active brain metastases or central nervous system cancer, as defined per protocol
4. Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
5. Known active infection with human immunodeficiency virus (HIV), Hepatitis B or C virus
6. Inability to discontinue proton-pump-inhibitor use before randomization
7. Patients who are pregnant or lactating
18 Years
ALL
No
Sponsors
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Calithera Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sam Whiting, M.D., Ph.D.
Role: STUDY_DIRECTOR
Calithera Biosciences, Inc
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
Penrose Cancer Center, Research Department
Colorado Springs, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)
Tampa, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
AMITA Health Cancer Institute & Outpatient Center
Hinsdale, Illinois, United States
Orchard Healthcare Research, Inc.
Skokie, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
HealthPartners Institute, Regions Cancer Care Center
Saint Paul, Minnesota, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mercy Hospital
Joplin, Missouri, United States
HCA Midwest Health
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
San Juan Oncology Associates, PC
Farmington, New Mexico, United States
Roswell Park Cancer Center
Buffalo, New York, United States
North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists
East Setauket, New York, United States
NYU Winthrop Hospital
Mineola, New York, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
INTEGRIS Cancer Institute of Oklahoma Proton Campus
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Saint Francis Hospital Cancer Center
Greenville, South Carolina, United States
West Cancer Center
Germantown, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Southern Highlands Private Hospital (Cancer Centre)
Bowral, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
MacQuarie University Hospital
North Ryde, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Tweed Hospital
Tweed Heads, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Mater Misericordiae Limited - Division of Cancer Services
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Ballarat Health Services
Ballarat, Victoria, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Goulburn Valley Health
Shepparton, Victoria, Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia
Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz
Besançon, , France
CHU de Bordeaux Hôpital Saint André
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre hospitalier universitaire (CHU) Henri-Mondor
Créteil, , France
Centre Georges-François Leclerc
Dijon, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli-Calmettes Service d'Urologie
Marseille, , France
Institut de Cancérologie de Montpellier (ICM)
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Européen Georges-Pompidou (HEGP)
Paris, , France
Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau
Saint-Herblain, , France
CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg)
Strasbourg, , France
IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud)
Toulouse, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy - Le département de Medecine oncologique
Villejuif, , France
Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology
Heidelberg, Baden-Wurttemberg, Germany
Technischen Universitat München - Urologische Klinik
München, Bavaria, Germany
Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik
Dresden, , Germany
Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Tübingen, Klinik für Urologie
Tübingen, , Germany
Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica
Brindisi, , Italy
S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona
Cremona, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale
Milan, , Italy
U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
Milan, , Italy
University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena)
Modena, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, , Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, , Italy
Unità Operativa (UO) di Oncologia Medica - ICS Maugeri
Pavia, , Italy
U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia
Rimini, , Italy
Policlinico Universitario A. Gemelli
Roma, , Italy
Policlinico Universitario Campus Bio-Medico
Rome, , Italy
Auckland City Hospital
Auckland, Grafton, New Zealand
Christchurch Hospital
Christchurch, South Island, New Zealand
Waikato Hospital
Hamilton, , New Zealand
Wellington Regional Hospital
Wellington, , New Zealand
Hospital Universitario Virgen del Rocío
Seville, Andalusia, Spain
Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia
Barcelona, , Spain
El Hospital Clínic i Provincial de Barcelona (HCPB)
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Institut Català d'Oncologia (ICO) L'Hospitalet
Barcelona, , Spain
Institut Català d'Oncologia
Girona, , Spain
HGU Gregorio Marañon
Madrid, , Spain
MD Anderson Cancer Center Madrid
Madrid, , Spain
El Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC) HM
Madrid, , Spain
Hospital Parc Taulí de Sabadell
Sabadell, , Spain
Hospital Universitario Virgen de Macarena
Seville, , Spain
Fundación Instituto Valencia d'Oncología (IVO)
Valencia, , Spain
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire, United Kingdom
Mount Vernon Cancer Centre
London, Middlesex, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital Campus
Nottingham, Nottinghamshire, United Kingdom
St. Bartholomew's Hospital, Barts Health NHS Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Sarah Cannon Research Institute UK Limited
London, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Tannir NM, Agarwal N, Porta C, Lawrence NJ, Motzer R, McGregor B, Lee RJ, Jain RK, Davis N, Appleman LJ, Goodman O Jr, Stadler WM, Gandhi S, Geynisman DM, Iacovelli R, Mellado B, Sepulveda Sanchez JM, Figlin R, Powles T, Akella L, Orford K, Escudier B. Efficacy and Safety of Telaglenastat Plus Cabozantinib vs Placebo Plus Cabozantinib in Patients With Advanced Renal Cell Carcinoma: The CANTATA Randomized Clinical Trial. JAMA Oncol. 2022 Oct 1;8(10):1411-1418. doi: 10.1001/jamaoncol.2022.3511.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CX-839-008
Identifier Type: -
Identifier Source: org_study_id
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