Alisertib-Taxol Combo Shows Promise in Recurrent Ovarian Cancer

Alisertib-Taxol Combo Shows Promise in Recurrent Ovarian Cancer
A combination of the investigational treatment alisertib and weekly Taxol (paclitaxel) showed promising anti-tumor activity in ovarian cancer patients treated in a Phase 1/2 trial, warranting further studies of the combination. The study, "Alisertib in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer or Recurrent Ovarian Cancer: A Randomized Clinical Trial," was published in JAMA Oncology. Alisertib is an oral inhibitor of the aurora kinase A, a protein involved in cell division that is often overproduced in ovarian and breast cancers and linked with poor prognosis. In preclinical and Phase 1 studies, the treatment has shown potent anti-tumor activity with a manageable safety profile. Taxol is a chemotherapy agent approved for several solid tumors, and is currently the standard of care for ovarian cancer patients who have failed platinum-based chemotherapies. But while the treatment is usually given in a three-week schedule, studies suggest that a weekly administration could improve patients' outcomes. Thus, researchers aimed to test a combination of alisertib and weekly Taxol in patients with advanced breast cancer and recurrent ovarian cancer. The Phase 1/2 trial (NCT01091428) included 191 patients at 33 sites across the U.S., France, and Poland. During Phase 1, both breast and ovarian cancer patients were included, and researchers tested ascending doses of the combination to determine the safest and more efficacious dose. Once this dose was determined, 142 patients with recurrent ovarian cancer were included in the Phase 2 part. There, patients were randomly assigned alisertib (40 mg twice daily) plus Taxol (60 mg/m2), or Taxol only (80 mg/m2). Before randomization, patients had been stratified according to their resp
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