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

NCT03057600 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CX-839-007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 25

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.

Conditions

Triple Negative Breast Cancer; TNBC - Triple-Negative Breast Cancer

Keywords

African ancestry; African American; CB-839; Glutaminase Inhibitor; Glutaminase; TNBC; Tumor Metabolism; Glutamine

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessment performed no less than 4 weeks after the criteria for response were first met.

  Maximum duration of follow-up for ORR was 14.8 months.

Secondary Outcomes (4)

• Progression Free Survival (PFS) as Assessed by Investigator

  Maximum duration of follow-up for PFS was 17.0 months.

• Overall Survival (OS)

  Maximum duration of follow-up for OS was 24.1 months.

• Duration of Response (DOR)

  Maximum duration of follow-up for DOR was 14.8 months.

• Clinical Benefit Rate (CBR)

  Maximum duration of follow-up for CBR was 14.8 months.

Study Arms (4)

Cohort 1 - African ancestry, 3rd line+

EXPERIMENTAL

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.

Drug: Paclitaxel; Drug: CB-839

Cohort 2 - African ancestry, 1st line

EXPERIMENTAL

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.

Drug: Paclitaxel; Drug: CB-839

Cohort 3 - Non-African ancestry, 3rd line+

EXPERIMENTAL

Intervention = Pac-CB combination 1. Participants do not self-identify as African ancestry. 2. Otherwise have the same criteria as Cohort 1.

Drug: Paclitaxel; Drug: CB-839

Cohort 4 - Non-African ancestry, 1st line

EXPERIMENTAL

Intervention = Pac-CB combination 1. Participants do not self-identify as African ancestry. 2. Otherwise have the same criteria as Cohort 2.

Drug: Paclitaxel; Drug: CB-839

Interventions

Paclitaxel DRUG

standard weekly paclitaxel in 28-day cycles

Also known as: Taxane

Cohort 1 - African ancestry, 3rd line+; Cohort 2 - African ancestry, 1st line; Cohort 3 - Non-African ancestry, 3rd line+; Cohort 4 - Non-African ancestry, 1st line

CB-839 DRUG

CB-839 administered as oral tablets twice daily (BID)

Also known as: telaglenastat

Cohort 1 - African ancestry, 3rd line+; Cohort 2 - African ancestry, 1st line; Cohort 3 - Non-African ancestry, 3rd line+; Cohort 4 - Non-African ancestry, 1st line

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Calithera Biosciences, Inc: lead

Study Sites (25)

University of Alabama at Brimingham

Birmingham, Alabama, 35294, United States

Location

University of South Alabama, Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Georgetown University - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami

Miami, Florida, 33176, United States

Location

Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

University Cancer and Blood Center

Athens, Georgia, 30607, United States

Location

Winship Cancer Institute - Emory University

Atlanta, Georgia, 30332, United States

Location

Northwest Georgia Oncology

Marietta, Georgia, 30060, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

JTCC at Hackensack UMC

Hackensack, New Jersey, 07601, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Womens Hospital - UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Charleston Hematology Oncology Associates

Charleston, South Carolina, 29414, United States

Location

Greenville Health System (GHS) Cancer Institute

Greenville, South Carolina, 29605, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Paclitaxel; taxane; CB-839

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Study Director
• Organization: Calithera Biosciences, Inc

clinicaltrials@calithera.com

650-870-1000

Study Officials

• Sam Whiting, MD, PhD

  Calithera Biosciences, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 20, 2017
• Study Start: May 1, 2017
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)