Clinical Trial: NCT03057600 - My Cancer Genome

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 twice daily (BID) CB-839 will be administered in combination with the full approved dose of paclitaxel.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03057600

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 Triple Negative Breast Cancer (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

Drug	Synonyms	Arms
Paclitaxel	Taxane	Cohort 1 - African ancestry, 3rd line+
CB-839	telaglenastat	Cohort 1 - African ancestry, 3rd line+

Purpose

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

Name	Type	Description	Interventions
Cohort 1 - African ancestry, 3rd line+	Experimental	Intervention = 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.	Paclitaxel CB-839
Cohort 2 - African ancestry, 1st line	Experimental	Intervention = 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.	Paclitaxel CB-839
Cohort 3 - Non-AA, 3rd line+	Experimental	Intervention = Pac-CB combination Patients do not self-identify as African ancestry. Otherwise have the same criteria as Cohort 1.	Paclitaxel CB-839
Cohort 4 - Non-AA, 1st line	Experimental	Intervention = Pac-CB combination Patients do not self-identify as African ancestry. Otherwise have the same criteria as Cohort 2.	Paclitaxel CB-839

Eligibility Criteria

        Key Inclusion Criteria:

          -  Meets criteria for 1 of the 4 defined study cohorts

          -  TNBC defined as estrogen receptor (ER) and progesterone receptor (PR) negative (<1%)
             and human epidermal growth factor receptor 2 (HER2) negative (fluorescent in situ
             hybridization [FISH] negative or immunohistochemistry (IHC) 0-1+)

             , progesterone receptor (PR), and .

          -  Metastatic disease or locally-advanced disease not amenable to curative intent
             treatment

          -  Adequate hepatic, renal, cardiac, and hematologic function

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Recovery to baseline or ≤ Grade 1 CTCAE ver.4.0

        Key Exclusion Criteria:

          -  Known brain metastases or central nervous system (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:	Completed
Lead Sponsor:	Calithera Biosciences, Inc

Trial Keywords

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

Last Updated

August 19, 2021

Clinical Trials /

Study of CB-839 in Combination w/ Paclitaxel in Patients of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)