Phase II Evaluation of Abemaciclib for Recurrent Ovarian or Endometrial Cancer with CDK46 Activation

What this Trial Is About

Researchers are evaluating how well abemaciclib works in treating patients with recurrent ovarian or endometrial cancer that shows activation of the CDK46 pathway. This phase II trial aims to estimate the proportion of patients who remain progression-free at 16 weeks and to assess response rates, progression-free survival, and safety of abemaciclib. The study also explores how genetic changes and hormone receptor levels relate to treatment response. Participants receive abemaciclib pills twice daily for 28-day cycles. Those with hormone receptor-positive tumors also take anastrozole or letrozole as standard care. Treatment continues until the cancer progresses or side effects become unacceptable. After stopping treatment, patients are followed for 30 days, then every 12 weeks for up to one year. During the study, participants undergo regular assessments including evaluations of tumor progression, response to treatment, and adverse events. Researchers collect data on progression-free survival and clinical benefit up to one year after treatment. Safety is monitored during and for 90 days after treatment, ensuring comprehensive follow-up throughout the trial period.

Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer