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CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

Sponsor
Calithera Biosciences, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT03428217
Collaborator
(none)
445
Enrollment
133
Locations
2
Arms
38.1
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in Renal Cell Carcinoma patients with at least one and not more than 2 prior therapies in the advanced or metastatic setting.

Study Design

Study Type:
Interventional
Actual Enrollment :
445 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a double blinded placebo-controlled study where patients will be randomized 1:1 to either CB-839 (telaglenastat) plus cabozantinib or placebo plus cabozantinibThis is a double blinded placebo-controlled study where patients will be randomized 1:1 to either CB-839 (telaglenastat) plus cabozantinib or placebo plus cabozantinib
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants, care providers, investigators and outcomes assessors are blinded to treatment. Progression free survival (PFS) will be assessed by a blinded Independent Radiology Committee for the primary endpoint of the study.
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)
Actual Study Start Date :
May 14, 2018
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Jul 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CB-Cabo

CB-839 orally twice daily + cabozantinib orally once daily

Drug: CB-839
Oral glutaminase inhibitor
Other Names:
  • telaglenastat

    • Drug: Cabozantinib
    Oral receptor tyrosine kinase inhibitor
    Other Names:
  • Cabometyx
  • Cabometriq

    		•
    Placebo Comparator: Pbo-Cabo

    Placebo orally twice daily + cabozantinib orally once daily

    Drug: Cabozantinib
    Oral receptor tyrosine kinase inhibitor
    Other Names:
  • Cabometyx
  • Cabometriq

    • Drug: Placebo
    Placebo tablets

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [18 months]

      An independent adjudication of radiological assessments will be conducted by Independent Radiology Committee (IRC) reviewing PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Secondary Outcome Measures

    1. Overall Survival (OS) of study patients treated with CB-Cabo vs Pbo-Cabo [36 months]

      Assessed by time from randomization to death by any cause

    2. PFS of patients treated with CB-Cabo vs Pbo-Cabo [18 months]

      Assessed by investigator per RECIST v1.1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component

    2. Adult patients

    3. Karnofsky Performance Score (KPS) ≥ 70%

    4. Measurable Disease per RECIST 1.1

    5. 1-2 lines of prior therapy for advanced or metastatic RCC including one anti-angiogenic therapy (any 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:

    1. Prior treatment with cabozantinib (or other MET inhibitor) or CB-839

    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 HIV, Hepatitis B or C virus

    6. Inability to discontinue proton-pump-inhibitor use before randomization

    7. Patients who are pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Mayo Clinic Cancer Center Phoenix Arizona United States 85054
    3 The University of Arizona Cancer Center Tucson Arizona United States 85724
    4 Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California United States 90048
    5 Stanford Cancer Center Palo Alto California United States 94304
    6 Salinas Valley Memorial Healthcare System Salinas California United States 93901
    7 St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    8 Penrose Cancer Center, Research Department Colorado Springs Colorado United States 80907
    9 Georgetown University Medical Center Washington District of Columbia United States 20007
    10 Florida Cancer Specialists Fort Myers Florida United States 33901
    11 University of Miami Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    12 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    13 H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center) Tampa Florida United States 33612
    14 Emory Winship Cancer Institute Atlanta Georgia United States 30322
    15 Georgia Cancer Center at Augusta University Augusta Georgia United States 30912
    16 Northwest Georgia Oncology Centers, PC Marietta Georgia United States 30060
    17 St. Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    18 Northwestern University Chicago Illinois United States 60611
    19 University of Chicago Chicago Illinois United States 60637
    20 NorthShore University HealthSystem Evanston Illinois United States 60201
    21 AMITA Health Cancer Institute & Outpatient Center Hinsdale Illinois United States 60521
    22 Orchard Healthcare Research, Inc. Skokie Illinois United States 60077
    23 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    24 Goshen Center for Cancer Care Goshen Indiana United States 46526
    25 East Jefferson General Hospital Metairie Louisiana United States 70006
    26 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    27 University of Maryland, Greenebaum Comprehensive Cancer Center Baltimore Maryland United States 21201
    28 Massachusetts General Hospital Boston Massachusetts United States 02114
    29 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    30 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    31 Karmanos Cancer Institute Detroit Michigan United States 48201
    32 HealthPartners Institute, Regions Cancer Care Center Saint Paul Minnesota United States 55101
    33 Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi United States 39401
    34 University of Mississippi Medical Center Jackson Mississippi United States 39216
    35 Mercy Hospital Joplin Missouri United States 64804
    36 HCA Midwest Health Kansas City Missouri United States 64132
    37 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    38 San Juan Oncology Associates, PC Farmington New Mexico United States 87401
    39 Roswell Park Cancer Center Buffalo New York United States 14263
    40 North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists East Setauket New York United States 11733
    41 NYU Winthrop Hospital Mineola New York United States 11501
    42 Northern Westchester Hospital Mount Kisco New York United States 10549
    43 Stony Brook Cancer Center Stony Brook New York United States 11794
    44 Levine Cancer Institute Charlotte North Carolina United States 28204
    45 Duke University Medical Center Durham North Carolina United States 27710
    46 INTEGRIS Cancer Institute of Oklahoma Proton Campus Oklahoma City Oklahoma United States 73142
    47 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    48 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    49 University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    50 Medical University of South Carolina Charleston South Carolina United States 29425
    51 Saint Francis Hospital Cancer Center Greenville South Carolina United States 29607
    52 West Cancer Center Germantown Tennessee United States 38138
    53 The Sarah Cannon Research Institute Nashville Tennessee United States 37203
    54 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    55 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
    56 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    57 University of Utah, Huntsman Cancer Institute Salt Lake City Utah United States 84112
    58 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    59 Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    60 Southern Highlands Private Hospital (Cancer Centre) Bowral New South Wales Australia 2576
    61 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
    62 MacQuarie University Hospital North Ryde New South Wales Australia 2109
    63 Liverpool Hospital Sydney New South Wales Australia 2170
    64 Tweed Hospital Tweed Heads New South Wales Australia 2485
    65 Pindara Private Hospital Benowa Queensland Australia 4217
    66 Cairns Hospital Cairns Queensland Australia 4870
    67 Mater Misericordiae Limited - Division of Cancer Services South Brisbane Queensland Australia 4101
    68 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
    69 Ballarat Health Services Ballarat Victoria Australia 3350
    70 Peninsula Private Hospital Frankston Victoria Australia 3199
    71 Cabrini Hospital Malvern Victoria Australia 3144
    72 Goulburn Valley Health Shepparton Victoria Australia 3630
    73 Hollywood Private Hospital Nedlands Western Australia Australia 6009
    74 Centre hospitalier régional universitaire (CHRU) de Besançon - Jean-Minjoz Besançon France 25030
    75 CHU de Bordeaux Hôpital Saint André Bordeaux France 33000
    76 Centre François Baclesse Caen Cedex 5 France 14076
    77 Centre Jean Perrin Clermont Ferrand France 63011
    78 Centre hospitalier universitaire (CHU) Henri-Mondor Créteil France 94010
    79 Centre Georges-François Leclerc Dijon France 21079
    80 Centre Léon Bérard Lyon France 69008
    81 Institut Paoli-Calmettes Service d'Urologie Marseille France 13009
    82 Institut de Cancérologie de Montpellier (ICM) Montpellier France 34298
    83 Centre Antoine Lacassagne Nice France 06189 Nice Cedex 2
    84 Hôpital Européen Georges-Pompidou (HEGP) Paris France 75015
    85 Institut de Cancérologie de l'Ouest (ICO) - Centre René Gauducheau Saint-Herblain France 44805
    86 CHU de Strasbourg (Les Hôpitaux Universitaires de Strasbourg) Strasbourg France 67091
    87 IUCTO Bureau des Essais Cliniques (Institut Claudius Regaud) Toulouse France 31059
    88 Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France CS 30519 54519
    89 Institut Gustave Roussy - Le département de Medecine oncologique Villejuif Cedex France 94805
    90 Medical University Heidelberg, NCT (National Center for Tumour Diseases), Medical Oncology Heidelberg Baden-Wuerttemberg Germany 69120
    91 Technischen Universitat München - Urologische Klinik München Bavaria Germany 81675
    92 Charité Universitätsmedizin Berlin, Dept. of Interdisciplinary Urology Berlin Germany 10117
    93 Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik Dresden Germany 01307
    94 Universitätsklinikum Essen (AöR) Westdeutsches Tumorzentrum Essen Germany 45147
    95 Medizinische Hochschule Hannover Hannover Germany 30625
    96 Universitätsklinikum Tübingen, Klinik für Urologie Tübingen Germany 72076
    97 Presidio Ospedaliero Antonio Perrino - U.O.C. Oncologia Medica Brindisi Italy 72100
    98 S.C. Oncologia - ASST Cremona P.O. Ospedale di Cremona Cremona Italy 26100
    99 U.O.C. ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo Milano Italy 20153
    100 Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy 20133
    101 Istituto Europeo di Oncologia - Divisione di Oncologia Medica Urogenitale e Cervico Facciale Milan Italy 20141
    102 University of Modena and Reggio Emilia (Azienda Ospedaliera-Universitaria Policlinico Modena) Modena Italy 41124
    103 Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Naples Italy 80131
    104 Azienda Ospedaliero Universitaria San Luigi Gonzaga Orbassano Italy 10043
    105 Unità Operativa (UO) di Oncologia Medica - ICS Maugeri Pavia Italy 27100
    106 U.O. Oncologia Ospedale degli Infermi - Dipartimento di Oncologia ed Ematologia Rimini Italy 47923
    107 Policlinico Universitario A. Gemelli Roma Italy 00168
    108 Policlinico Universitario Campus Bio-Medico Rome Italy 00128
    109 Auckland City Hospital Auckland Grafton New Zealand 1023
    110 Christchurch Hospital Christchurch South Island New Zealand 8011
    111 Waikato Hospital Hamilton New Zealand 3240
    112 Wellington Regional Hospital Wellington New Zealand 6021
    113 Hospital Universitario Virgen del Rocío Seville Andalucia Spain 41013
    114 Hospital Universitari VHIO - Vall d'Hebron Departamento de Oncologia Barcelona Spain 08035
    115 El Hospital Clínic i Provincial de Barcelona (HCPB) Barcelona Spain 08036
    116 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041
    117 Institut Català d'Oncologia (ICO) L'Hospitalet Barcelona Spain 08908
    118 Institut Català d'Oncologia Girona Spain 17007
    119 HGU Gregorio Marañon Madrid Spain 28009
    120 MD Anderson Cancer Center Madrid Madrid Spain 28033
    121 El Hospital Universitario 12 de Octubre Madrid Spain 28041
    122 Centro Integral Oncologico Clara Campal (CIOCC) HM Madrid Spain 28050
    123 Hospital Parc Taulí de Sabadell Sabadell Spain 08208
    124 Hospital Universitario Virgen de Macarena Seville Spain 41009
    125 Fundación Instituto Valencia d'Oncología (IVO) Valencia Spain 46009
    126 The Christie NHS Foundation Trust Manchester Greater Manchester United Kingdom M20 4BX
    127 Beatson West of Scotland Cancer Centre Glasgow Lanarkshire United Kingdom G12 0YN
    128 Mount Vernon Cancer Centre London Middlesex United Kingdom HA6 2RN
    129 Nottingham University Hospitals NHS Trust - City Hospital Campus Nottingham Nottinghamshire United Kingdom NG5 1PB
    130 St. Bartholomew's Hospital, Barts Health NHS Trust London United Kingdom EC1A7BE
    131 The Royal Marsden NHS Foundation Trust London United Kingdom SW3 6JJ
    132 Sarah Cannon Research Institute UK Limited London United Kingdom W1G 6AD
    133 Southampton General Hospital Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Calithera Biosciences, Inc

    Investigators

    • Study Director: Sam Whiting, M.D., Ph.D., Calithera Biosciences, Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Calithera Biosciences, Inc
    ClinicalTrials.gov Identifier:
    NCT03428217
    Other Study ID Numbers:
    • CX-839-008
    First Posted:
    Feb 9, 2018
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Calithera Biosciences, Inc
    Tumor Metabolism
    RCC
    Glutaminase Inhibitor
    CB-839
    CANTATA
    TKI
    Tyrosine Kinase Inhibitor
    cabozantinib
    Cabometyx
    Cometriq
    glutaminase
    glutamine
    renal cell
    clear cell
    kidney cancer
    cMET
    MET
    HGFR
    telaglenastat
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell

    Study Results

    No Results Posted as of Aug 23, 2021