A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) Plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients With Advanced Solid Tumors

Inclusion Criteria:

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

- Patients must have tumors determined to be easily accessible for biopsy (e.g.
pleural-based lesions, peripheral lymph nodes, soft tissue metastases, or large liver
metastases)

- Archival tissue block or paraffin sample from archival tissue block (approximately 10
sections) for use in pharmacodynamic correlative studies must be available

- No known active brain metastases

- Patients with previously treated brain metastases are eligible, provided they
are not accompanied by seizures and a baseline brain magnetic resonance imaging
(MRI) scan demonstrates no current evidence of brain metastases

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

- Life expectancy > 12 weeks

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

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

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN
(=< 5 times ULN if liver metastases are present)

- Alkaline phosphatase =< 2.0 times ULN (=< 5 times ULN if bone or liver metastases are
present)

- Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min

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

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to, during, and for 3 months
after completion of study treatment

- Must be able to reliably tolerate and/or receive oral medications

- No history of allergic reactions attributed to the following:

- Camptothecin derivatives (e.g., topotecan hydrochloride, irinotecan
hydrochloride, or exatecan mesylate)

- Any ingredients contained within the liquid irinotecan hydrochloride solution
(e.g., sorbitol)

- Any antiemetics or antidiarrheals appropriate for administration with study
therapy (e.g., loperamide or dexamethasone)

- No prior history of seizures

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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

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

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
and recovered

- More than 3 weeks since prior minimal radiotherapy (i.e., =< 5% of total marrow
volume)

- More than 4 weeks since prior radiotherapy (i.e., > 5% of total marrow volume)

- No prior radiotherapy to >= 50% of total marrow volume

- Histologically or cytologically confirmed metastatic or unresectable malignancy
meeting 1 of the following criteria:

- Standard curative or palliative measures do not exist or are no longer effective

- Irinotecan hydrochloride is considered to be a viable therapy regimen

- Patients enrolled on the expansion portion of the study will consist of two cohorts:
those patients who are triple-negative, BRCA-mutant positive and those patients who
have triple-negative, non-BRCA mutated breast cancer

- Patients with solid hematologic malignancies (Hodgkin or non-Hodgkin lymphoma) are
eligible provided a bone marrow has been performed within 6 weeks of treatment

- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
guidelines

- Patients must be negative for carrying the UGT1A1*28 allele (also called (TA)7)

- More than 4 weeks since prior experimental (i.e., non-Food and Drug Administration
[FDA] approved) therapy or immunotherapy and recovered

- Males receiving treatment for prostate cancer must be maintained at castrate levels
of testosterone by continuation of luteinizing-releasing hormone agonists

- No cytochrome P450 CYP3A4 isoform-inducing drugs (e.g. phenytoin, phenobarbital,
carbamazepine, rifampin, rifabutin, ketoconazole, St. John's Wort)

- No other investigational agents within 4 weeks of study entry

- No chronic growth factor support (e.g., filgrastim [G-CSF], pegfilgrastim) for
maintenance of white blood cell counts or granulocyte counts

- No other concurrent anticancer therapy (cytotoxic, biologic, radiation, or hormonal
other than for replacement) except medications for supportive care that may
potentially have an anticancer effect (i.e., megestrol acetate, bisphosphonates)
started 1 month prior to study

- Patients with active seizure or a history of seizure are excluded

- Patients with known active brain metastases should be excluded from this clinical
trial; patients with prior treated brain metastases are allowed, providing that they
were not accompanied by seizures and that a baseline brain MRI scan prior to study
entry demonstrates no current evidence of brain metastases; all patients with CNS
metastases must be stable for > 3 months after treatment and off steroid treatment
prior to study enrollment