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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Calithera Biosciences, Inc
Study ID
NCT03428217
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CB-839 — DRUG
    Oral glutaminase inhibitor
  • Cabozantinib — DRUG
    Oral receptor tyrosine kinase inhibitor
  • Placebo — DRUG
    Placebo tablets

Study Details

Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).

Key Dates

Start date
Apr 24, 2018
Status verified
Feb 2023
Primary completion
Aug 31, 2020
Completion
Jul 16, 2021

Study Design

Enrollment
444 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by the Independent Radiology Committee (IRC) [ Time Frame: Up to the primary analysis data cut-off date of 31 Aug 2020. Maximum duration of follow-up for PFS was 22.14 months. ]

Locations (59)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Mayo Clinic Cancer CenterPhoenixArizona85054-
The University of Arizona Cancer CenterTucsonArizona85724-
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
Stanford Cancer CenterPalo AltoCalifornia94304-
Salinas Valley Memorial Healthcare SystemSalinasCalifornia93901-
St. Joseph Heritage HealthcareSanta RosaCalifornia95403-
Penrose Cancer Center, Research DepartmentColorado SpringsColorado80907-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Florida Cancer SpecialistsFort MyersFlorida33901-
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
H.Lee Moffitt Cancer & Research Institute (Moffitt Cancer Center)TampaFlorida33612-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
Northwest Georgia Oncology Centers, PCMariettaGeorgia30060-
St. Luke's Mountain States Tumor InstituteBoiseIdaho83712-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
NorthShore University HealthSystemEvanstonIllinois60201-
AMITA Health Cancer Institute & Outpatient CenterHinsdaleIllinois60521-
Orchard Healthcare Research, Inc.SkokieIllinois60077-
Northwestern Medicine Cancer Center WarrenvilleWarrenvilleIllinois60555-
Goshen Center for Cancer CareGoshenIndiana46526-
East Jefferson General HospitalMetairieLouisiana70006-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
HealthPartners Institute, Regions Cancer Care CenterSaint PaulMinnesota55101-
Hattiesburg Clinic Hematology/OncologyHattiesburgMississippi39401-
University of Mississippi Medical CenterJacksonMississippi39216-
Mercy HospitalJoplinMissouri64804-
HCA Midwest HealthKansas CityMissouri64132-
Comprehensive Cancer Centers of NevadaLas VegasNevada89148-
San Juan Oncology Associates, PCFarmingtonNew Mexico87401-
Roswell Park Cancer CenterBuffaloNew York14263-
North Shore Hematology Oncology Associates PC dba NY Cancer and Blood SpecialistsEast SetauketNew York11733-
NYU Winthrop HospitalMineolaNew York11501-
Northern Westchester HospitalMount KiscoNew York10549-
Stony Brook Cancer CenterStony BrookNew York11794-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
INTEGRIS Cancer Institute of Oklahoma Proton CampusOklahoma CityOklahoma73142-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Allegheny General HospitalPittsburghPennsylvania15212-
University of Pittsburgh Medical Center (UPMC) Hillman Cancer CenterPittsburghPennsylvania15232-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Saint Francis Hospital Cancer CenterGreenvilleSouth Carolina29607-
West Cancer CenterGermantownTennessee38138-
The Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Utah, Huntsman Cancer InstituteSalt Lake CityUtah84112-
Kadlec Clinic Hematology and OncologyKennewickWashington99336-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

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