- Histological or cytological diagnosis of locally advanced or metastatic solid tumor
that is resistant to standard therapy or for which no standard therapy is available.
- ECOG Performance Status 0 or 1.
- Adequate Bone Marrow, Renal and Liver Function.
- Patients with known symptomatic brain metastases requiring steroids.
- Current use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of
BCRP within 1 week or 5 half lives which ever is longer prior to the first dose of
study treatment.
- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception.
[Dose Expansion Part]
Inclusion Criteria:
- Histologically or cytologically confirmed carcinoma of the breast.
- Locally advanced breast cancer that is not amenable to curative radiation or surgery
and/or metastatic disease.
- Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or
BRCA2 mutation by Myriad Genetics' BRACAnalysis CDx test.
- No more than 3 prior chemotherapy-inclusive regimens for locally advanced or
metastatic disease.
- Have measurable lesion by the RECIST v.1.1.
- ECOG Performance Status 0-2.
- Adequate Bone Marrow, Renal and Liver Function.
Exclusion Criteria:
- First-line locally advanced or metastatic breast cancer with no prior neoadjuvant and
adjuvant chemotherapy.
- Prior treatment with a PARP inhibitor.
- Objective disease progression while receiving platinum chemotherapy administered for
locally advanced or metastatic disease.
- HER2 positive breast cancer.
- Active inflammatory breast cancer.
- Central nervous system (CNS) metastases.
- Current or anticipated use within 7 days prior to the first dose of study treatment,
or anticipated use during the study of strong P-gp inhibitors.
- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception.