Nektar Therapeutics has initiated a phase III global clinical trial evaluating NKTR-102 as a single agent in women with metastatic breast cancer. NKTR-102 is a next-generation topoisomerase I inhibitor designed using Nektar's proprietary polymer conjugate technology, and is being developed in multiple tumor settings. The BEACON study is designed to include approximately 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting.
BEACON is a phase III, open-label, randomized, multicenter study of NKTR-102
and will be conducted in approximately 160 sites worldwide including North America, Eastern and Western Europe, and certain countries in Asia/Pacific. Patients will be randomized on a 1:1 basis to receive 145 mg/m2 of single-agent NKTR-102 once every three weeks or a single agent of physician's choice. The physician's choice agents will include: ixabepilone, vinorelbine, gemcitabine, eribulin, or a taxane. Randomization will be stratified by geographic region, prior use of eribulin and receptor status.