Spots Global Cancer Trial Database for Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
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Trial Identification
Brief Title: Study of CB-839 in Combination w/ Paclitaxel in Participants 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
Study ID: NCT03057600
Study Description
Brief 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.
Detailed 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, District of Columbia, United States
Washington Cancer Institute, Washington, 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, Saint 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
Contact Details
Name: Sam Whiting, MD, PhD
Affiliation: Calithera Biosciences, Inc
Role: STUDY_DIRECTOR
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