A clinical trial to assess the effectiveness of abemaciclib in patients with endometrial cancer (EC) is expected to reach its primary completion date in July 2025, according to a report published recently on clinicaltrials.gov.
Abemaciclib is an antineoplastic agent that inhibits the G1 phase of the cell cycle and prevents tumor proliferation. Unlike other similar drugs, abemaciclib has a relatively low incidence of bone marrow suppression. While the drug is approved for the treatment of advanced or metastatic breast cancer, its application for EC is still under investigation.
“Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer,” the authors wrote.
This phase II clinical trial began in 2020 and aims to further assess the effectiveness of abemaciclib in patients with EC. The trial has an estimated enrollment of 32 patients.
Participants in the study received abemaciclib twice daily in 28-day cycles, with treatment continuing in the absence of disease progression or severe adverse effects. Follow-up was conducted 30 days after the initial cycle and then every 12 weeks for up to 12 months.
To be eligible for the trial, patients must meet specific criteria, including a histologically confirmed diagnosis of EC and test results showing the presence of the hormone receptor required for abemaciclib to be effective. Additionally, patients must have undergone at least one prior chemotherapy regimen and achieved full recovery from any chemotherapy-associated adverse effects.
The primary objective of the study is to determine the proportion of patients who remain progression-free after 16 weeks of treatment. Secondary objectives include evaluating the overall response to treatment using the Response Evaluation Criteria in Solid Tumors (RECIST), a standardized tool used to assess tumor response based on objective measures such as lesion size and appearance.
Sign up here to get the latest news, perspectives, and information about EC sent directly to your inbox. Registration is free and only takes a minute.
