Clinical Trials

Title   Calithera CX-839-007
Principal Investigator/ Physician   Carole Norden, MD
Protocol┬áNo.   CX-839-007
Open Date   07/14/2017
Gender   Both
Cancer Site   Breast
Status   Open
Sponsor   Calithera
Contact Email   MCI Clinical Trials

Protocol: A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Comination with Paclitaxel in Patients with Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non-African Ancestry

 Inclusion Criteria: Meets criteria for 1 of the 4 defined study cohorts; TNBC defined as ER and PR negative (<1%) and HER-2 negative (FISH negative or IHC 0-1+);  Metastatic disease or locally-advanced disease not amenable to curative intent treatment; Adequate hepatic, renal, cardiac, and hematologic function; ECOG performance status 0-1; Recovery to baseline or ≤ Grade 1 CTCAE.

 Exclusion Criteria: Known brain metastases or 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.


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