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:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

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

Conditions

  • Advanced Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma

Interventions

DrugSynonymsArms
CB-839telaglenastatCB-Cabo
CabozantinibCabometyx, CabometriqCB-Cabo
PlaceboPbo-Cabo

Purpose

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.

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.
    

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:

          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
      
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: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

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:Completed
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
  • telaglenastat

Last Updated

August 23, 2021