PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients with Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST, v1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN); if liver function abnormalities are due to hepatic metastasis, then AST and ALT may be =< 5 x ULN
• Total serum bilirubin =< 1.5 x ULN
• Calculated creatinine clearance of >= 40 ml/min; as per Cockcroft-Gault formula
• Hemoglobin >= 9.0 g/dL
• Absolute neutrophil count (ANC) >= 1500/mm^3
• Platelet count >= 100,000/mm^3
• Able to take oral medications
• Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
• Sexually active patients must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 3 months after the last dose of BMN 673
• Females of childbearing potential must have a negative serum or urine pregnancy test at screening

Exclusion Criteria

• Has not recovered (recovery is defined as National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version (v)4.03] grade =< 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion
• Prior treatment with a PARP inhibitor
• Prior allergic reaction or severe intolerance to either irinotecan or temozolomide
• History of central nervous system (CNS) metastasis that are untreated or not stable
• Any antitumor systemic cytotoxic therapies within 28 days prior to enrollment (6 weeks for nitrosoureas or mitomycin-C); prior high-dose chemotherapy with bone marrow or stem cell transplant is excluded
• Is known to have human immunodeficiency virus (HIV) or has active hepatitis C virus (HCV), or active hepatitis B virus (HBV)
• Has had major surgery within 28 days prior to enrollment
• Active gastrointestinal tract disease with malabsorption syndrome
• Requirement for IV alimentation
• Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
• Symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication (atrial fibrillation is permitted)
• Use of any investigational product or investigational medical device within 28 days prior to enrollment
• Concurrent disease or condition that would interfere with study participation or safety, such as: * Active, clinically significant infection requiring the use of parenteral anti-microbial agents, or grade > 2 by NCI CTCAE (v 4.03) within 14 days prior to enrollment * Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders * Non-healing wound, ulcer, or bone fracture * Bone marrow disorder including myelodysplasia