Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer

Men and women, 18 years or older with advanced malignancies for which no standard therapy is available.

Dose Escalation: Patients with any solid tumor malignancies

Does Expansion:

Patients with advanced malignancies that have germline and/or somatic BRCA mutations (cohort gBRCA) Or

Triple negative (TN) metastatic breast cancer without known BRCA mutation (cohort TNBC). Tumors will be considered TN when:

Estrogen receptor (ER) expression \<1%

Progesterone receptor (PR) expression \<1%

Her2 negative as per the American Society of Clinical Oncology (ASCO) guidelines

Paclitaxel expansion: any solid tumor malignancy with potential benefit from this combination and paclitaxel (ASP).

Consent to screening tumor biopsy (for accessible tumors when appropriate) \[optional in dose escalation, mandatory in dose expansion\]

Part 2 only: Measureable tumor (RECIST1.1)

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

Adequate organ function:

Absolute neutrophil count (ANC) ≥ 1.5 X 109/L

Hemoglobin (Hgb) ≥9.5 g/dL(transfusion before treatment is allowable if more than 3 days prior to study start)

Platelets (plt) ≥ 100 x 109/L

Potassium within normal range, or correctable with supplements;

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x Upper Limit Normal (ULN)

Serum total bilirubin ≤ 1.5 x ULN

Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 60ml/min

Females of child-bearing potential (FCBP) must have negative serum pregnancy test within 7 days before starting study treatment and willingness to adhere to acceptable forms of birth control (a physician-approved contraceptive method: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) for a minimum of 4 weeks following the discontinuation of study treatment.

FCBP is defined as a sexually mature woman who:

Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or,

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time during the preceding 12 consecutive months

Male subjects with female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and for a minimum of 4 weeks following the discontinuation of study treatment.

Ability to take oral medications

What this study is about