Breast Cancer NCT01306032 Registration - Eligibility/Pre-Registration Worksheet - 3158687v1.0 Standard Patient Identifier Standard Demographics (ii) Inclusion Criteria Has histologically documented (confirmed by the department of pathology at the enrolling institution prior to patient registration) BRCA-positive ovarian cancer, primary peritoneal or ovarian high-grade serous carcinoma, fallopian tube cancer, triple-negative breast cancer with distant metastasis, or low-grade lymphoid malignancies (NHL) as specified below: Yes
No
Indicate Cancer histology: Has disease progressed following at least one line of standard therapy? Yes
No
Has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >=20 mm with conventional techniques or as >=10 mm with spiral CT scan? Yes
No
Prior therapy completed >=4 weeks prior to enrollment on protocol (at least six weeks out from nitrosoureas and mitomycin C) and associated toxicities resolved to eligibility levels. Yes
No
Prior radiation completed >=4 weeks prior to study enrollment, and associated toxicities resolved to eligibility levels. At least 2 weeks since prior investigational agent administered as part of a Phase 0 study, and associated toxicities resolved to eligibility levels. Age >= 18 years Yes
No
Karnofsky Performance Status (>=70%, see Appendix A site to complete box with actual score) Life expectancy >3 months Yes
No
Absolute neutrophil count (ANC) >=1,500/mm^3 Yes
No
Platelet count >= 100,000/mm^3 Yes
No
Total bilirubin <= 1.5 x ULN Yes
No
AST (SGOT) and ALT (SGPT) <= 2.5x institutional upper limits of normal Yes
No
Creatinine < 1.5x institutional upper limits of normal OR Creatinine clearance >=60 mL/min for patients with creatinine levels >=1.5x institutional upper limit of normal. Yes
No
Able to swallow whole capsule? Yes
No
Exclusion Criteria Has 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 requirement? Yes
No
Pregnant? ([Note: women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study.]) Breastfeeding? Has germ cell or borderline ovarian epithelial tumors Yes
No
Has had seizure within last 3 months while on anti-seizure medication for CNS metastases Has ulcerative colitis, inflammatory bowel disease, partial or complete small bowel obstruction, or other gastrointestinal condition that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, and active peptic ulcer disease). Yes
No
Has had prior treatment with any PARP inhibitors that were administered in combination with cyclophosphamide Is receiving other investigational agents Yes
No
Pre Study Evaluations Does the patient have bone marrow involvement? (for lymphoma patients only, if "Yes" please provide date in the following question, select "NA" if patient is not a lymphoma patient) Laboratory Studies Will Be Conducted 1 Week Prior To Starting Study Drug Will Include