Phase I Study of Veliparib (ABT-888) in Combination With Cisplatin Plus Gemcitabine in Advanced Biliary, Pancreatic, Urothelial, and Non-small Cell Lung Cancer

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced
biliary/pancreatic cancer, urothelial cancer, or non-small cell lung cancer that is
metastatic or unresectable

- Patients with known CNS metastases should be excluded from this clinical trial

- ECOG performance status ≤ 2 (Karnofsky ≥ 60%)

- Life expectancy of greater than 12 weeks

- Absolute neutrophil count ≥ 1,500/mcL

- Platelets ≥ 100,000/mcL

- Total bilirubin within normal institutional limits

- AST/ALT ≤ 2.5 times institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min

- QTc interval on ECG ≤ 0.48 seconds by Bazett's calculation (≤ CTCAE v.4 grade 2)

- Not pregnant or nursing

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

- Patients must be able to swallow pills and have no significant impairment in
gastrointestinal absorption

- Patients with known or suspected germline mutation in BRCA1 or BRCA2 are eligible to
participate

- Patients in study screening (primarily those with pancreatic cancer) who have a
family history that is suspicious for BRCA1 or BRCA2 germline mutation should be
assessed by the BRCAPRO computer program to quantitate the likelihood of
harboring a deleterious BRCA mutation

- Patients found to have a BRCAPRO probability score of ≥ 20% should undergo
formal full-sequence BRCA testing

- Patients in screening with a BRCAPRO probability of ≥ 20% who decline genetic
testing are not eligible to participate in this trial due to the potential to
confound safety assessment

- No uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements

- HIV-positive patients are eligible

- No active seizure or history of seizure disorder

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to veliparib (ABT-888) or other agents used in this study

- No peripheral neuropathy greater than grade1

- No prior systemic treatment

- No prior cytotoxic chemotherapy (neoadjuvant, adjuvant, or metastatic setting)

- At least 4 weeks since major surgery or radiation therapy

- Patients may not be receiving any other investigational agents