Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
NCT ID: NCT03057600
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2017-05-01
2019-11-25
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 - African ancestry, 3rd line+
Intervention = Paclitaxel- CB-839 (Pac-CB) combination
1. Participants must self-identify as African ancestry (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.
Paclitaxel
standard weekly paclitaxel in 28-day cycles
CB-839
CB-839 administered as oral tablets twice daily (BID)
Cohort 2 - African ancestry, 1st line
Intervention = Pac-CB combination
1. Participants 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.
Paclitaxel
standard weekly paclitaxel in 28-day cycles
CB-839
CB-839 administered as oral tablets twice daily (BID)
Cohort 3 - Non-African ancestry, 3rd line+
Intervention = Pac-CB combination
1. Participants do not self-identify as African ancestry.
2. Otherwise have the same criteria as Cohort 1.
Paclitaxel
standard weekly paclitaxel in 28-day cycles
CB-839
CB-839 administered as oral tablets twice daily (BID)
Cohort 4 - Non-African ancestry, 1st line
Intervention = Pac-CB combination
1. Participants do not self-identify as African ancestry.
2. Otherwise have the same criteria as Cohort 2.
Paclitaxel
standard weekly paclitaxel in 28-day cycles
CB-839
CB-839 administered as oral tablets twice daily (BID)
Interventions
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Paclitaxel
standard weekly paclitaxel in 28-day cycles
CB-839
CB-839 administered as oral tablets twice daily (BID)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* TNBC, defined as estrogen receptor (ER) and progesterone receptor (PR) negative (\< 1% by immunohistochemistry) and human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization \[FISH\] negative)
* 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 Common Terminology Criteria for Adverse Events (CTCAE) version.4.0
Exclusion Criteria
* Unable to receive oral medications
* Known hypersensitivity to Cremophor®-based agents
* Major surgery within 28 days of Cycle 1 Day 1
18 Years
FEMALE
No
Sponsors
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Calithera Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sam Whiting, MD, PhD
Role: STUDY_DIRECTOR
Calithera Biosciences, Inc
Locations
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University of Alabama at Brimingham
Birmingham, Alabama, United States
University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
University Cancer and Blood Center
Athens, Georgia, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
Northwest Georgia Oncology
Marietta, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
JTCC at Hackensack UMC
Hackensack, New Jersey, United States
Columbia University
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Womens Hospital - UPMC
Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
Greenville Health System (GHS) Cancer Institute
Greenville, South Carolina, United States
West Cancer Center
Germantown, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
MD Anderson
Houston, Texas, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CX-839-007
Identifier Type: -
Identifier Source: org_study_id
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