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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Calithera Biosciences, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Triple Negative Breast Cancer
• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	standard weekly paclitaxel in 28-day cycles
DRUG	CB-839	CB-839 administered as oral tablets twice daily (BID)

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-11-25
• Completion: 2019-11-25
• First posted: 2017-02-20
• Last updated: 2022-09-28
• Results posted: 2022-09-28

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study