Breast Cancer Clinical Trial

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

Summary

CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in participants 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.

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Full Description

Participants 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

View Eligibility Criteria

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% 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

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 Cycle 1 Day 1

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT03057600

Recruitment Status:

Completed

Sponsor:

Calithera Biosciences, Inc

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There are 24 Locations for this study

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University of Alabama at Brimingham
Birmingham Alabama, 35294, United States
University of South Alabama, Mitchell Cancer Institute
Mobile Alabama, 36604, United States
Yale Cancer Center
New Haven Connecticut, 06511, United States
Georgetown University - Lombardi Comprehensive Cancer Center
Washington District of Columbia, 20007, United States
Washington Cancer Institute
Washington District of Columbia, 20010, United States
University of Miami
Miami Florida, 33176, United States
Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
University Cancer and Blood Center
Athens Georgia, 30607, United States
Winship Cancer Institute - Emory University
Atlanta Georgia, 30332, United States
Northwest Georgia Oncology
Marietta Georgia, 30060, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Weinberg Cancer Institute at Franklin Square
Baltimore Maryland, 21237, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Saint Louis University
Saint Louis Missouri, 63110, United States
JTCC at Hackensack UMC
Hackensack New Jersey, 07601, United States
Columbia University
New York New York, 10032, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Magee Womens Hospital - UPMC
Pittsburgh Pennsylvania, 15213, United States
Charleston Hematology Oncology Associates
Charleston South Carolina, 29414, United States
Greenville Health System (GHS) Cancer Institute
Greenville South Carolina, 29605, United States
West Cancer Center
Germantown Tennessee, 38138, United States
Baylor College of Medicine
Houston Texas, 77030, United States
MD Anderson
Houston Texas, 77030, United States
Northwest Medical Specialties, PLLC
Tacoma Washington, 98405, United States
Froedtert and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

52

Study ID:

NCT03057600

Recruitment Status:

Completed

Sponsor:


Calithera Biosciences, Inc

How clear is this clinincal trial information?

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