Overview
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
Completed
Trial end date:
2019-11-25
2019-11-25
Target enrollment:
0
0
Participant gender:
Female
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Calithera Biosciences, IncTreatments:
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