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

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ClinicalTrials.gov Identifier: NCT03428217
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Brief Summary:
This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.

Condition or disease Intervention/treatment Phase
Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Drug: CB-839 Drug: Cabozantinib Drug: Placebo Phase 2

Detailed Description:
This study is a randomized Phase 2 evaluation of CB-839 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 298 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 plus cabozantinib or placebo plus cabozantinib
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind in place with blinded Independent Radiology Committee reviewing adjudicated progression free survival of patients
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study 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) - CANTATA
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CB-Cabo
CB-839 orally twice daily + cabozantinib orally once daily
Drug: CB-839
Oral glutaminase inhibitor
Other Name: Glutaminase inhibitor
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
Other Name: Placebo Tablets



Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 18 months ]
    Assessed by Independent Radiology Committee (IRC)-adjudicated 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 [ Time Frame: 36 months ]
    Assessed by time from randomization to death by any cause

  2. PFS of patients treated with CB-Cabo vs Pbo-Cabo [ Time Frame: 18 months ]
    Assessed by investigator per RECIST v1.1



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
  • Adult patients
  • Karnofsky Performance Score (KPS) ≥ 70%
  • Measurable Disease per RECIST 1.1
  • 1-2 lines of prior therapy for advanced or metastatic RCC including at least one antiangiogenic therapy or nivolumab + ipilimumab
  • Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

  • Prior treatment with cabozantinib (or other MET inhibitor) or CB-839
  • Receipt of other anticancer therapy within 2 - 6 weeks, depending on the treatment
  • Untreated or active brain metastases or central nervous system cancer, as defined per protocol
  • Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
  • Known active infection with HIV, Hepatitis B or C virus
  • Requirement for continued proton pump inhibitor after randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428217


Contacts
Contact: Clinical Trials Administrator 650-870-1000 clinicaltrials@calithera.com
Contact: Clinical Admin 650-870-1000 clinicaltrials@calithera.com

Locations
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Nancy Dawson, MD    202-444-2198    Nad28@georgetown.edu   
Principal Investigator: Nancy Dawson, MD         
United States, Georgia
Georgia Cancer Center at Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Jigarkumar Parikh, MD    706-721-1206    cancer_center_trials@augusta.edu   
Principal Investigator: Jigarkumar Parikh, MD         
Northwest Georgia Oncology Centers, PC Recruiting
Marietta, Georgia, United States, 30060
Contact: Steve McCune, MD    770-281-5010      
Principal Investigator: Steve McCune, MD         
United States, Indiana
Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
Contact: Jen Hughey    574-364-2974    jhughey@goshenhealth.com   
Principal Investigator: Sachin Agarwal, MD         
United States, Louisiana
East Jefferson General Hospital Recruiting
Metairie, Louisiana, United States, 70006
Contact: Nicole Guttierrez    504-503-5368    nguttirrez@ejgh.org   
Principal Investigator: Thomas Cosgriff, MD         
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Tammy McBeth    601-261-1700    tmcbeth@forrestgeneral.com   
Principal Investigator: John Hrom, MD         
United States, New Mexico
San Juan Oncology Associates, PC Recruiting
Farmington, New Mexico, United States, 87401
Contact: Rosemarie Mestas    505-564-6874    rosemarie@sjonc.com   
Principal Investigator: Sardar Imam, MD         
United States, New York
North Shore Hematology Oncology Associates PC dba NY Cancer and Blood Specialists Recruiting
East Setauket, New York, United States, 11733
Contact: David Chu, MD    631-675-5075    researchpi@nycancer.com   
Principal Investigator: David Chu, MD         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Jennifer Brown    516-663-3115    JLBrown@nyuwinthrop.org   
Principal Investigator: Mary O'Keeffe, MD         
Northern Westchester Hospital Recruiting
Mount Kisco, New York, United States, 10549
Contact: Jonathan Goldberg, MD    914-241-1050    jgoldberg@cmmedical.com   
Principal Investigator: Jonathan Goldberg, MD         
Stony Brook Cancer Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Audrey Anderson    631-638-0829    audrey.anderson@stonybrookmedicine.edu   
Principal Investigator: Yue Zhang, MD         
United States, South Carolina
Saint Francis Hospital Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Amanda Lowery    864-603-6214    Amanda_Lowery@bshsi.org   
Principal Investigator: Robert Siegel, MD         
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Amanda Fletcher    901-683-0055    afletcher@westclinic.com   
Principal Investigator: Daniel Vaena, MD         
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Nizar Tannir, MD    713-563-1895    ntannir@mdanderson.org   
Principal Investigator: Nizar Tannir, MD         
United States, Utah
University of Utah, Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Jill Broghammer    801-213-6232    jill.broghammer@hci.utah.edu   
Principal Investigator: Neeraj Agarwal, MD         
United States, Washington
Kadlec Clinic Hematology and Oncology Recruiting
Kennewick, Washington, United States, 99336
Contact: Heather Johansen    509-783-4637 ext 228    Heather.johansen@kadlec.org   
Principal Investigator: Rangaswamy Chintapatla, MD         
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
Study Director: Bridget O'Keeffe, PhD Calithera Biosciences, Inc

Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT03428217     History of Changes
Other Study ID Numbers: CX-839-008
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases