StudyFinder
A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer
Recruiting
The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.
Female
18 years and over
Inclusion Criteria:
• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
Exclusion Criteria:
• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Ipatasertib, Procedure: Magnetic Resonance Imaging, Drug: Megestrol Acetate
Cancer, Women's Health
Endometrial Cancer, Metastatic Endometrial Cancer, Clinics and Surgery Center (CSC)