Veliparib in Combination With Carboplatin and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor that has evidence of metastaticspread (stage IV) or is locally advanced and unresectable

• Patients with breast cancer may have estrogen receptor positive or negative (ER+or ER-) disease

• Patients with breast cancer may not be human epidermal growth receptor -2 (HER2)-positive ( 3+), or fluorescent in situ hybridization (FISH) ratio > 2.2

• Patients in the biopsy expansion cohort must have "triple negative" breast cancerdefined as:

• Estrogen receptor staining < 10%; progesterone receptor staining <10%; Her 2 < 2.2 by FISH, or immunohistochemistry (IHC) 0-2+

• Patients may have been previously treated

• In the dose escalation cohort, there is no limit to prior therapies

• In the expansion cohort, patients may have only had 1-3 prior regimens formetastatic disease

• Patients may have received prior carboplatin, paclitaxel, or poly (ADP-ribose)polymerase (PARP) inhibitor therapy as part of their previous treatment regimens

• However, patients may NOT have received prior therapy with paclitaxel,carboplatin, and PARP inhibitor in combination

• Patients must not have received chemotherapy within 4 weeks of starting study (or 6 weeks if prior treatment was with carmustine [BCNU] or mitomycin C)

• Patients must not have received radiation within 2 weeks of starting study

• Eastern Cooperative Oncology Group (ECOG) performance status (PS)< 2 (Karnofsky > 60%)

• Life expectancy > 2 months

• Absolute neutrophil count (ANC) >= 1,500/mcL

• Platelet count >= 100,000/mcL

• Total bilirubin =< 1.5 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times ULN

• Creatinine normal within normal institutional limits OR creatinine clearance >= 60mL/min/1.73m^2 for patients with creatinine levels above institutional normal

• Must able to swallow pills

• Pregnant women are excluded from this study

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entryand for the duration of study participation; should a woman become pregnant orsuspect she is pregnant while participating in this study, she should inform hertreating physician immediately

• Ability to understand and the willingness to sign a written informed consent document

• Patients enrolled in the expanded cohort with mandatory biopsies must:

• Have accessible tumors

• Not be on therapeutic anticoagulation

• Have signed informed consent form

Exclusion Criteria:

• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas ormitomycin C) or radiotherapy within 2 weeks (4 weeks for central nervous system [CNS]metastases) prior to entering the study or those who have not recovered from adverseevents due to agents administered more than 4 weeks earlier

• Patients may not be receiving any other investigational agents

• History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to veliparib or other agents used in study

• Concurrent treatment with bisphosphonates, or other bone anti-resorptive agent such asdenosumab is allowed; concurrent treatment with hormonal therapy (tamoxifen, ovariansuppression with gonadotropin-releasing hormone [GNRH] agonists, aromatase inhibitors)or trastuzumab therapy is NOT allowed in breast cancer patients; prostate cancerpatients may continue GNRH agents

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements

• Pregnant women are excluded from this study; breastfeeding should be discontinued ifthe mother is treated with veliparib

• Active seizure or history of seizure disorder

• Patients with CNS metastases must be stable after therapy for CNS metastases (such assurgery, radiotherapy or stereotactic radiosurgery) for > 3 months and must be offsteroid treatment prior to study enrollment

• Patients who undergo biopsy as part of the study in the expanded dose cohort shouldnot be on anti-coagulants or have a pre-existing coagulopathy

• Peripheral neuropathy of severity greater than grade 1