Clinical trial NCT03057600: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
Keywords: African ancestry
African American
CB-839
Glutaminase Inhibitor
Glutaminase
TNBC
Tumor Metabolism
Glutamine
Lead sponsor: Calithera Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2017-02-20
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants 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
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Maximum duration of follow-up for ORR was 14.8 months.
Secondary outcomes:
measure: Progression Free Survival (PFS) as Assessed by Investigator
timeFrame: Maximum duration of follow-up for PFS was 17.0 months.
measure: Overall Survival (OS)
timeFrame: Maximum duration of follow-up for OS was 24.1 months.
measure: Duration of Response (DOR)
timeFrame: Maximum duration of follow-up for DOR was 14.8 months.
measure: Clinical Benefit Rate (CBR)
timeFrame: Maximum duration of follow-up for CBR was 14.8 months.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Brimingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute
state: Alabama
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University - Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center and Research Institute
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute - Emory University
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Hackensack
country: United States
facility: JTCC at Hackensack UMC
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital - UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System (GHS) Cancer Institute
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Calithera Biosciences, Inc
name: Sam Whiting, MD, PhD
role: STUDY_DIRECTOR
References: