A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

Exclusion Criteria

• •Prior exposure to PARP inhibitors
• •Subject has received or is planning to receive live vaccines within 30 days prior to the first dose of oral treatment and while participating in the trial
• •Known BRCA1 or BRCA2 mutation
• •Pathologic diagnosis of prostate cancer as the cancer to be treated in cohort B
• •Simultaneous enrollment in any other interventional clinical trial
• •Major surgery ≤ 3 weeks of study enrollment (Subject must have recovered from any effects of any major sugery.)
• •Investigational therapy ≤ 4 weeks of first day of dosing of study drug
• •Radiotherapy to \> 20% of the bone marrow within 4 weeks of the first dose of study drug
• •Known hypersensitivity to the components of niraparib or the excipients
• •Platelet or red blood cell transfusion ≤ 4 weeks of first dose of study drug
• •Colony-stimulating factors within 4 weeks prior to starting protocol therapy
• •More than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treatment physician and approved by the PI\] may be included).
• •Known, active symptomatic brain or leptomeningeal metastases
• •Subject has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment.
• •Known history of myelodysplastic syndrome or acute myeloid leukemia
• •Females or males of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for at least 180 days after the last dose of study drug.
• •Females who are pregnant or breastfeeding
• •History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician or study PI.
• •Prisoners or subjects who are involuntarily incarcerated.
• •Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• •Subjects demonstrating an inability to comply with the study and/or follow-up procedures