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

• Status: Completed
• Trial end date: 2019-11-25
• Target enrollment: 0
• Participant gender: Female

Summary

CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in patients 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calithera Biosciences, Inc
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Taxane

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%) and human epidermal growth factor receptor 2 (HER2) negative (fluorescent in situ hybridization [FISH] negative or immunohistochemistry (IHC) 0-1+)

, progesterone receptor (PR), and .

• 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 CTCAE ver.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 C1D1