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Triple Negative Breast CancerPhase 2NCT03057600

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

A Phase 2 study testing Paclitaxel and CB-839 in people with Triple Negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Calithera Biosciences, Inc at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Paclitaxel and CB-839
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
25 sitesUnited States
Study dates
1 May 2017to 25 Nov 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • University Cancer and Blood Center

    Athens, Georgia, 30607

  • Winship Cancer Institute - Emory University

    Atlanta, Georgia, 30332

  • Weinberg Cancer Institute at Franklin Square

    Baltimore, Maryland, 21237

  • University of Alabama at Brimingham

    Birmingham, Alabama, 35294

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29414

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Greenville Health System (GHS) Cancer Institute

    Greenville, South Carolina, 29605

  • JTCC at Hackensack UMC

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine

    Houston, Texas, 77030

  • MD Anderson

    Houston, Texas, 77030

  • Northwest Georgia Oncology

    Marietta, Georgia, 30060

  • University of Miami

    Miami, Florida, 33176

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of South Alabama, Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Magee Womens Hospital - UPMC

    Pittsburgh, Pennsylvania, 15213

  • Saint Louis University

    St Louis, Missouri, 63110

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Georgetown University - Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Paclitaxel, CB-839
Keywords
African ancestry, African American, CB-839, Glutaminase Inhibitor, Glutaminase, TNBC, Tumor Metabolism, Glutamine
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxane

    standard weekly paclitaxel in 28-day cycles

  • CB-839Drug

    Also called telaglenastat

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

Study groups in NCT03057600
Study groupRoleWhat they receive
Cohort 1 - African ancestry, 3rd line+ExperimentalIntervention = 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.
Receives: Drug: Paclitaxel; Drug: CB-839
Cohort 2 - African ancestry, 1st lineExperimentalIntervention = 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.
Receives: Drug: Paclitaxel; Drug: CB-839
Cohort 3 - Non-African ancestry, 3rd line+ExperimentalIntervention = Pac-CB combination 1. Participants do not self-identify as African ancestry. 2. Otherwise have the same criteria as Cohort 1.
Receives: Drug: Paclitaxel; Drug: CB-839
Cohort 4 - Non-African ancestry, 1st lineExperimentalIntervention = Pac-CB combination 1. Participants do not self-identify as African ancestry. 2. Otherwise have the same criteria as Cohort 2.
Receives: Drug: Paclitaxel; Drug: CB-839

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Progression Free Survival (PFS) as Assessed by Investigator

    PFS was defined as time from the first dose date to the earlier of either progression of disease per RECIST v1.1 or death from any cause. The duration of progression-free survival was censored at the date of last radiographic disease if the patient was alive and progression free at the time of analysis data cutoff, disease progression or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol TNBC treatment prior to documentation of disease progression. Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% confidence interval (CI) is used.

    Progressive Disease (PD) per RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.

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

  2. Overall Survival (OS)

    Overall survival is defined as the time from the first dose date to death due to any cause. For patients alive at time of analysis, overall survival will be censored at the time when the patient is last known to be alive.Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% CI is used. Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5.

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

  3. Duration of Response (DOR)

    Duration of response is defined as the time between the first documentation of a confirmed PR or a CR to the first documentation of PD or death, whichever occurs first. The duration of response will be censored at the date of last radiographic disease if the patient is alive and progression free at the time of database lock, disease progression or death occurs after missing data for two consecutive radiographic disease assessments, or patient receives non-protocol TNBC treatment prior to documentation of disease progression.

    RECIST v1.1 criteria:

    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. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.

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

  4. Clinical Benefit Rate (CBR)

    Clinical Benefit Rate is defined as the percentage of patients with best response of CR, PR, or SD per RECIST v1.1 criteria lasting ≥ 16 weeks for 3rd line + patients and ≥ 24 weeks for 1st line patients. 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.

    Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2017
  2. Study start1 May 2017
  3. Primary completion25 Nov 2019
  4. Study completion25 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057600
Sponsor's protocol ID
CX-839-007
Status last verified
Sep 2022
First submitted
10 Feb 2017
Last updated
28 Sep 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and CB-839 in people with Triple Negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Calithera Biosciences, Inc at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Maximum duration of follow-up for ORR was 14.8 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03057600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

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