MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

Inclusion Criteria

• •1. Female participants 18 years or older.
• •2. Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
• •3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• •4. Postmenopausal at least 1 year, OR
• •* Surgically sterile, OR
• •* If childbearing potential, agree to 2 effective methods of nonhormonal contraception, or agree to completely abstain from heterosexual intercourse.
• •5. Able to provide written informed consent.
• •6. Within 7 days before study:
• •* Absolute neutrophils (ANC) ≥ 1,500/μL
• •* Platelets ≥100,000/ μL
• •* Total bilirubin must be \< 1.5 times upper limit of the normal (ULN)
• •* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be ≤ 2.5 times the ULN. AST and ALT may be elevated up to 5 times the ULN if ascribed to metastatic liver disease.
• •* Creatinine clearance ≥ 30 mL/minute
• •7. Platinum-refractory or -resistant disease.
• •8. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) OR Cancer antigen (CA) 125 level of \> 40 units/mL AND clinical evidence disease.
• •9. Recovered from effects of prior therapy.