Clinical Trials /

Study of CB-839 in Combination w/ Paclitaxel in Patients of African Ancestry and Non-African Ancestry With Advanced TNBC

NCT03057600

Description:

CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in patients of African ancestry and non-African ancestry with advanced triple negative breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg BID CB-839 will be administered in combination with the full approved dose of paclitaxel.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of CB-839 in Combination w/ Paclitaxel in Patients of African Ancestry and Non-African Ancestry With Advanced TNBC
  • Official Title: A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Combination With Paclitaxel in Patients With Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non-African Ancestry

Clinical Trial IDs

  • ORG STUDY ID: CX-839-007
  • NCT ID: NCT03057600

Conditions

  • Triple Negative Breast Cancer
  • TNBC - Triple-Negative Breast Cancer

Interventions

DrugSynonymsArms
Pac-CBGlutaminase inhibitor, Taxane, CB-839, PaclitaxelCohort 1 - African ancestry, 3rd line+

Purpose

CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in patients of African ancestry and non-African ancestry with advanced triple negative breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg BID CB-839 will be administered in combination with the full approved dose of paclitaxel.

Detailed Description

      CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in
      patients of African ancestry and non-African ancestry with advanced triple negative breast
      cancer. Multiple single-arm cohorts will be enrolled in which 800 mg BID CB-839 will be
      administered in combination with the full approved dose of paclitaxel.

      Patients will be enrolled into 4 cohorts, as follows:

        -  Cohort 1: patients of African ancestry with 2 or more lines of prior therapy for
           metastatic disease

        -  Cohort 2: patients of African ancestry with no prior lines of therapy for metastatic
           disease

        -  Cohort 3: same as cohort 1 but in patients of non-African ancestry

        -  Cohort 4: same as cohort 2 but in patients of non-African ancestry
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1 - African ancestry, 3rd line+ExperimentalIntervention = Pac-CB combination Patients must self-identify as African ancestry (AA; includes African American). At least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane. Prior taxane (paclitaxel, docetaxel, or nab-paclitaxel) for advanced/metastatic disease is required but must not have been received in the immediate prior line of therapy. Systemic neoadjuvant and/or adjuvant therapy is considered a line of therapy for advanced/metastatic disease if the time to recurrence from completion of treatment was ≤ 12 mo.
  • Pac-CB
Cohort 2 - African ancestry, 1st lineExperimentalIntervention = Pac-CB combination Patients must self-identify as African ancestry (includes African American). No prior systemic therapy for advanced or metastatic disease. Systemic neoadjuvant or adjuvant therapy, including taxane, is allowed if time to recurrence was > 12 mo.
  • Pac-CB
Cohort 3 - Non-AA, 3rd line+ExperimentalIntervention = Pac-CB combination Patients do not self-identify as African ancestry. Otherwise have the same criteria as Cohort 1.
  • Pac-CB
Cohort 4 - Non-AA, 1st lineExperimentalIntervention = Pac-CB combination Patients do not self-identify as African ancestry. Otherwise have the same criteria as Cohort 2.
  • Pac-CB

Eligibility Criteria

        Key Inclusion Criteria:

          -  Meets criteria for 1 of the 4 defined study cohorts

          -  TNBC defined as ER and PR negative (<1%) and HER-2 negative (FISH negative or IHC
             0-1+)

          -  Metastatic disease or locally-advanced disease not amenable to curative intent
             treatment

          -  Adequate hepatic, renal, cardiac, and hematologic function

          -  ECOG performance status 0-1

          -  Recovery to baseline or ≤ Grade 1 CTCAE ver.4.0

        Key Exclusion Criteria:

          -  Known brain metastases or CNS cancer unless adequately treated with radiotherapy
             and/or surgery and stable for ≥ 2 mo

          -  Unable to receive oral medications

          -  Known hypersensitivity to Cremophor®-based agents

          -  Major surgery within 28 days of C1D1
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Approximately 15 months]
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:Approximately 18 months
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 36 months
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Up to 18 months
Safety Issue:
Description:
Measure:Clinical benefit rate (CBR)
Time Frame:Approximately 18 months
Safety Issue:
Description:

Details

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

Trial Keywords

  • African ancestry
  • African American
  • CB-839
  • Glutaminase Inhibitor
  • Glutaminase
  • TNBC
  • Tumor Metabolism
  • Glutamine

Last Updated

August 18, 2017