Clinical Trials /

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

NCT03428217

Description:

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.

Related Conditions:
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CB-839 With Cabozantinib vs. Placebo With Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CX-839-008
  • NCT ID: NCT03428217

Conditions

  • Advanced Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma

Interventions

DrugSynonymsArms
CB-839Glutaminase inhibitorCB-Cabo
CabozantinibCabometyx, CabometriqCB-Cabo
PlaceboPlacebo TabletsPbo-Cabo

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
CB-CaboExperimentalCB-839 orally twice daily + cabozantinib orally once daily
  • CB-839
  • Cabozantinib
Pbo-CaboPlacebo ComparatorPlacebo orally twice daily + cabozantinib orally once daily
  • Cabozantinib
  • Placebo

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:18 months
Safety Issue:
Description:Assessed by Independent Radiology Committee (IRC)-adjudicated PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

Measure:Overall Survival (OS) of study patients treated with CB-Cabo vs Pbo-Cabo
Time Frame:36 months
Safety Issue:
Description:Assessed by time from randomization to death by any cause
Measure:PFS of patients treated with CB-Cabo vs Pbo-Cabo
Time Frame:18 months
Safety Issue:
Description:Assessed by investigator per RECIST v1.1

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Calithera Biosciences, Inc

Trial Keywords

  • 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

Last Updated

April 3, 2018