Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)

Inclusion Criteria

• •1. 18 years of age or older, female, any race
• •2. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
• •3. High grade (or grade 3) serous histology or known to have gBRCAmut
• •4. Has received at least 2 previous lines of platinum-containing therapy (not necessarily consecutive), and has disease that was considered platinum sensitive following the penultimate platinum line (more than 6-months period between penultimate platinum regimen and progression of disease)
• •5. Has responded to the last platinum line (PR or CR)
• •6. No more than 8 weeks have elapsed from completion of the last platinum regimen and the patient is still not progressing after response
• •7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• •8. Adequate bone marrow, kidney and liver function, defined as follows:
• •1. Absolute neutrophil count ≥ 1,500/µL
• •2. Platelets ≥ 100,000/µL
• •3. Hemoglobin ≥ 9 g/dL
• •4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
• •5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
• •6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• •9. Patient receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
• •10. Patient must have a negative urine or serum pregnancy test within 7 days prior to taking study treatment if childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment or use adequate barrier methods throughout the study. Non-childbearing potential is defined as follows (by other than medical reasons): ≥45 years of age and has not had menses for \>1 year; patients with amenorrhea for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation; Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment.
• •11. Patient must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
• •12. Patient must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
• •13. Patients must have normal blood pressure or adequately treated and controlled hypertension. (i.e. systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg)