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

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ClinicalTrials.gov Identifier: NCT03057600
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer TNBC - Triple-Negative Breast Cancer Drug: Pac-CB Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to one of 4 arms depending on the number of prior lines of therapy they have received and whether or not they have African ancestry
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Cohort 1 - African ancestry, 3rd line+

Intervention = Pac-CB combination

  1. Patients must self-identify as African ancestry (AA; includes African American).
  2. 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.
Drug: Pac-CB
CB-839 administered as oral tablets twice daily (BID) in combination with standard weekly paclitaxel in 28-day cycles
Other Names:
  • Glutaminase inhibitor
  • Taxane
  • CB-839
  • Paclitaxel

Experimental: Cohort 2 - African ancestry, 1st line

Intervention = Pac-CB combination

  1. Patients must self-identify as African ancestry (includes African American).
  2. 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.
Drug: Pac-CB
CB-839 administered as oral tablets twice daily (BID) in combination with standard weekly paclitaxel in 28-day cycles
Other Names:
  • Glutaminase inhibitor
  • Taxane
  • CB-839
  • Paclitaxel

Experimental: Cohort 3 - Non-AA, 3rd line+

Intervention = Pac-CB combination

  1. Patients do not self-identify as African ancestry.
  2. Otherwise have the same criteria as Cohort 1.
Drug: Pac-CB
CB-839 administered as oral tablets twice daily (BID) in combination with standard weekly paclitaxel in 28-day cycles
Other Names:
  • Glutaminase inhibitor
  • Taxane
  • CB-839
  • Paclitaxel

Experimental: Cohort 4 - Non-AA, 1st line

Intervention = Pac-CB combination

  1. Patients do not self-identify as African ancestry.
  2. Otherwise have the same criteria as Cohort 2.
Drug: Pac-CB
CB-839 administered as oral tablets twice daily (BID) in combination with standard weekly paclitaxel in 28-day cycles
Other Names:
  • Glutaminase inhibitor
  • Taxane
  • CB-839
  • Paclitaxel




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Approximately 15 months] ]

Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Approximately 18 months ]
  2. Overall survival (OS) [ Time Frame: Up to 36 months ]
  3. Duration of response (DOR) [ Time Frame: Up to 18 months ]
  4. Clinical benefit rate (CBR) [ Time Frame: Approximately 18 months ]

Other Outcome Measures:
  1. Type, incidence, severity, seriousness, and relatedness of adverse events per CTCAE v.4.0 [ Time Frame: Approximately 15 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03057600


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

  Show 25 Study Locations
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
Study Director: Sam Whiting, MD, PhD Calithera Biosciences, Inc

Additional Information:
Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT03057600     History of Changes
Other Study ID Numbers: CX-839-007
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: May 24, 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:
African ancestry
African American
CB-839
Glutaminase Inhibitor
Glutaminase
TNBC
Tumor Metabolism
Glutamine

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Taxane
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action