Statement: The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel, supported by the primary trial results, is 40 mg orally, twice daily (BID) on Days 1-3, 8-10 and 15-17
Primary_evidence: Outcome Measurement:    Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel   The MTD is defined as the dose range at which  1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting 7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other Grade 3 nonhematologic toxicity, with following exceptions: Grade 3 nausea/emesis, Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.   Time frame: Cycle 1 (Up to 28 days) Results 1:    Arm/Group Title: Alisertib + Paclitaxel (Phase 1)   Arm/Group Description: Participants with ovarian cancer received alisertib (MLN8237) 10, 20, 30 or 40 mg, orally, twice daily (BID) on Days 1-3, 8-10 and 15-17, combined with weekly paclitaxel 60 or 80 mg/m^2, intravenous infusion, weekly (Days 1, 8, 15) in 28-day cycles in Phase 1 (Up to 37 cycles).   Overall Number of Participants Analyzed: 49   Measure Type: Number   Unit of Measure: mg  40