NCT02725268.

Trial name or title	Phase 2 study of MLN0128 (a dual TORC1/2 inhibitor), combination of MLN0128 with MLN1117 (a PI3Kα inhibitor), paclitaxel and combination of MLN0128 with paclitaxel in women with endometrial cancer
Methods	Accrual: April 2016 to September 2019 Accrual target: 242 Multicentre, phase 2 RCT, conducted in Europe
Participants	Advanced, recurrent, or persistent endometrial cancer and has relapsed or is refractory to curative therapy or established treatments Prior platinum‐based chemotherapy permitted (but not more than 2 prior chemotherapy regimens). Prior chemotherapy/radiation therapy and/or consolidation/maintenance therapy allowed Measurable disease by RECIST 1.1 ECOG performance status of 0 to 2 Exclude: previous treatment with any weekly taxane or PI3K, AKT, dual PI3K/mTOR inhibitors, TORC1/2 or TORC1 inhibitors
Interventions	Intervention I: paclitaxel 80 mg/m2 weekly (days 1, 8 and 15) of 28‐week cycle and MLN0128 4 mg (days 2 ‐ 4, 9 ‐ 11, 16 ‐ 18, 23 to 25) of 28‐day cycle Intervention II: MLN0128 30 mg once weekly (days 1, 8, 15, 22) of 28‐week cycle Intervention III: MLN0128 4 mg and MLN1117 200 mg (days 1 ‐ 3, 8 ‐ 10, 15 ‐ 17 and 22 ‐ 24) of 28‐week cycle Comparator: paclitaxel 80 mg/m2 weekly (days 1, 8 and 15) of 28‐week cycle
Outcomes	Primary outcome: ‐ Progression‐free survival Secondary outcomes: ‐ Percentage of participants who experience at least 1 treatment‐emergent adverse event ‐Overall survival ‐ Time to progression ‐ Overall response rate ‐ Clinical benefit rate ‐ Clinical benefit rate at week 16
Starting date	Study start date: March 2016 Estimated completion date: 30 September 2019
Contact information	Takeda study registration call centre
Notes	NCT02725268 Sponsors: Millennium Pharmaceuticals Inc, European Network of Translational Research in Ovarian Cancer, European Network of Individualized Treatment in Endometrial Cancer