Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: McAlarnen, Lindsey
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/study/NCT05538897?term=NCT05538897&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVES:
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 I) 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. (Phase II) III. Compare the toxicity of the combination of ipatasertib with megestrol acetate to megestrol acetate alone. (Phase II)
SECONDARY OBJECTIVES:
I. Compare objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the two arms.
II. Examine the pharmacokinetics of ipatasertib + megestrol acetate to assess potential drug-drug interactions.
III. Assess the association between biomarkers and response to therapy.
EXPLORATORY OBJECTIVE:
I. Explore whether pS6/total S6 and pPRAS40/total PRAS40 expression is impacted by the use of ipatasertib and megestrol acetate.