Ongoing Study of Afuresertib Plus Paclitaxel in Platinum-Resistant Ovarian Cancer
Posted: Thursday, October 15, 2020
The oral, small-molecule pan-AKT kinase inhibitor afuresertib (GSK2110183), when combined with other paclitaxel, may lower AKT activity and resensitize cancer cells to taxanes. At least that is the hope of the research team of Thomas J. Herzog, MD, of the University of Cincinnati Cancer Center. The PROFECTA-11 trial design, which is evaluating the efficacy of afuresertib with weekly paclitaxel for platinum-resistant ovarian cancer, was presented during the 2020 International Gynecologic Cancer Society (IGCS) Annual Global Meeting (Abstract 1171). A previous study showed an overall response rate of 32% in patients treated with a combination of afuresertib plus chemotherapy.
NCT04374630 is an open-label, randomized, active-controlled global phase II clinical study designed to evaluate the safety and efficacy of this combination therapy in patients with platinum-resistant ovarian cancer. The treatment consists of oral afuresertib (125 mg daily) plus intravenous paclitaxel (80 mg/m2 on days 1, 8, and 15) every 3 weeks versus paclitaxel alone. Progression-free survival is the primary endpoint; secondary endpoints include the overall rate of response, duration of response, overall survival, disease control rate, and CA-125 level response.
A total of 141 patients with platinum-resistant ovarian cancer from the United States and China will be enrolled in the study. Patients must have high-grade serous, endometrioid, or clear cell ovarian cancer confirmed by histology or cytology and must have previously received between one and three systemic treatments to qualify for this study. In addition, patients must either be ineligible for or have already been treated with bevacizumab and/or PARP inhibitors. Participants will be randomly assigned in a 2:1 ratio to receive combination therapy or paclitaxel alone.
The first patient was enrolled and received an initial dosage on July 7, 2020. The trial is now accruing patients and is expected to be completed in mid-2022.
Disclosure: The authors reported no conflicts of interest.