Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial

Exclusion Criteria

• •Patients simultaneously enrolled in any therapeutic clinical trial
• •Patients have had investigational therapy administered within the past 4 weeks
• •Current or anticipated use of other investigational agents while participating in this study.
• •Patient has had prior treatment with a known poly polymerase inhibitor
• •Psychiatric illness/social situations that would limit compliance with study requirements.
• •Pregnant, breast feeding or expecting to conceive children while receiving study treatment and for 180 days after the last dose of study treatment. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants.
• •Patients must not have a known hypersensitivity to the components of niraparib or the excipients
• •Patients must not have had major surgery within the last 3 weeks of starting the study and patient must have recovered from any effects of any major surgery
• •Patients must not have had radiotherapy encompassing more than 20% of the bone marrow within 2 weeks or any radiation therapy within 1 week prior to Day 1 of protocol therapy
• •Patients must not be immuno-compromised. Patients with splenectomy are allowed.
• •Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
• •Patients must not have current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with the patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participate
• •Patients must not have known, symptomatic brain or leptomeningeal metastases
• •Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)