A Phase 1 Study of ABT-888 (Veliparib) in Combination With Weekly Carboplatin and Paclitaxel in Advanced Solid Tumors

Inclusion Criteria:

- Histologically or cytologically confirmed solid tumor that has evidence of metastatic
spread (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 HER2-positive ( 3+), or fluorescent in
situ hybridization (FISH) ratio > 2.2

- Patients in the biopsy expansion cohort must have "triple negative" breast
cancer defined as:

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

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

- Have accessible tumors

- Not be on therapeutic anticoagulation

- Have signed informed consent form

- 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 for
metastatic 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 with central nervous system (CNS) metastases must be stable after therapy
for CNS metastases (such as surgery, radiotherapy or stereotactic radiosurgery) for >
3 months and must be off steroid treatment prior to study enrollment

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 (Karnofsky PS
60-100%)

- Life expectancy > 2 months

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

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

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 times ULN

- Creatinine normal OR creatinine clearance >= 60 mL/min

- Able to swallow pills

- Not pregnant or nursing

- Negative pregnancy test

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal, barrier method of birth control, or abstinence) prior to study entry and
for the duration of study participation

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to veliparib or other agents used in study

- No uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- No active seizure or history of seizure disorder

- No peripheral neuropathy of severity greater than grade 1

- More than 4 weeks since prior chemotherapy (6 weeks for carmustine [BCNU],
nitrosoureas, or mitomycin C) and recovered

- More than 2 weeks since prior radiotherapy

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

- No other concurrent investigational agents