A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer
Phase I: Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose. Phase II: Compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid adenocarcinoma of the endometrium. Compare the toxicity of the combination of ipatasertib with megestrol acetate to megestrol acetate alone. Secondary Objectives Compare objective response rate per RECIST 1.1 between the two arms. Examine the pharmacokinetics of ipatasertib + megestrol acetate to assess potential drug-drug interactions Assess the association between biomarkers and response to therapy. Exploratory Objectives Explore whether pS6/total S6 and pPRAS40/total PRAS40 expression is impacted by the use of ipatasertib and megestrol acetate.