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Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers

Trying Ipatasertib with Megestrol Acetate for advanced endometrial cancer.

Recruiting
18 years and older
Female
Phase 1/2

This research study is for women with endometrial cancer that has come back (recurrent) or spread (metastatic). It tests a new treatment combining two drugs: ipatasertib and megestrol acetate. Ipatasertib may stop cancer cells from growing by blocking enzymes they need. Megestrol acetate lowers estrogen, a hormone some cancer cells use to grow. The study compares this combination to using megestrol acetate alone to see which works better.

Participants will take pills daily in 28-day cycles. They will have regular CT or MRI scans and blood tests to check the cancer’s response. The study is in two phases. Phase Ib checks for side effects and sets the best dose. Phase II compares treatment effectiveness between two groups: one taking both drugs and the other taking only megestrol acetate.

  • Length: Phase I follow-up is 30 days post-treatment; Phase II follow-up is up to 5 years.
  • Visits: Regular scans and blood tests during treatment cycles.
  • Risks: Potential side effects from the drug combination.
Study details
    FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
    FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
    Metastatic Endometrial Endometrioid Adenocarcinoma
    Recurrent Endometrial Endometrioid Adenocarcinoma

NCT05538897

National Cancer Institute (NCI)

15 March 2025

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