Ensayos clínicos

Inclusion Criteria:

• Patients with histologically documented: BRCA-positive ovarian cancer (documented deleterious BRCA1/2 mutation or a BRCAPRO score of ≥ 30%), primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer (no requirement for BRCA status), triple-negative breast cancer (documented ER negative, PR negative, and Her2/neu negative from the original pathology report if considered adequate, or per ASCO/CAP guidelines (51, 52)) with metastasis to distant sites, low-grade lymphoid malignancies (NHL) as described below, whose disease has progressed following at least one line of standard therapy: Follicle center lymphoma, follicular or diffuse—recurrent/refractory, Marginal zone B-cell lymphoma: splenic, nodal, extranodal (this includes MALT)—recurrent/refractory, Lymphoplasmacytic lymphoma—recurrent/refractory, SLL (absolute lymphocytes count below 5,000). Pathology must be confirmed by the registering institution. For patients who are eligible for the study due to a history of BRCA1/2 mutation, documented evidence of their mutation status must be provided prior to enrolling on the study.
• Patients must have 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.
• Any prior therapy or radiotherapy must have been completed ≥ 4 weeks (> 6 weeks for nitrosoureas or mitomycin C) prior to enrollment on protocol, and the participant must have recovered to eligibility levels from prior toxicity. Patients must be ≥ 2 weeks since any investigational agent administered as part of a Phase 0 study, and should have recovered to eligibility levels from any toxicities.
• Patients who have had prior treatment with any PARP inhibitors are eligible unless the PARP inhibitor was administered in combination with cyclophosphamide.
• Patients with bone metastases or hypercalcemia on bisphosphonate treatment are eligible to participate.
• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ABT-888 in patients < 18 years of age, children are excluded from this study, but may be eligible for future pediatric Phase I combination trials.
• Karnofsky performance status ≥ 70%.
• Life expectancy > 3 months.
• Additional Inclusion Criteria may apply.

Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Patients with 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.
• Patients with germ cell and borderline ovarian epithelial tumors.
• Patients who have received prior cyclophosphamide should not be excluded solely because of receiving prior cyclophosphamide.
• Patients with history of CNS metastases who have received treatment and who have been on stable doses of anti-seizure medicine and had no seizures x 3 months will be eligible.
• Additional Exclusion Criteria may apply.