Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery

Exclusion Criteria

• •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• •Previous enrollment in the present study
• •Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
• •Histology showing mucinous or low grade epithelial carcinoma
• •Participation in another clinical study with an investigational product (IP) during the last 4 weeks
• •History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease \>= 5 years before the first dose of study drug and of low potential risk for recurrence, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, and/or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ
• •Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, mean QT interval corrected for heart rate with Fridericia's correction (QTcF) prolongation \> 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome
• •Any unresolved toxicity (\> CTCAE grade 2) from previous anti-cancer therapy, excluding alopecia
• •History of hypersensitivity to olaparib or its excipients
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or otherwise immunocompromised subjects, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
• •History of leptomeningeal carcinomatosis
• •Subjects who are pregnant and/or breast-feeding
• •Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results
• •Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids. The subject can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
• •Subjects with uncontrolled seizures
• •Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
• •Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
• •Any previous treatment with PARP inhibitor, including olaparib
• •Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks
• •Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's wort ) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
• •Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
• •Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
• •Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 28 days prior to treatment)
• •Non-English speakers will be excluded from participating in the patient-reported outcomes component of the study