WASHINGTON (dpa-AFX) - Nektar Therapeutics (NKTR) said it has initiated its pivotal Phase 3 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 around 840 metastatic breast cancer patients who have had prior treatment with anthracycline, taxane and capecitabine in either the adjuvant or metastatic setting. It is a Phase 3, open-label, randomized, multicenter study of NKTR-102 and will be conducted in about 160 sites worldwide including North America, Eastern and Western Europe and certain countries in Asia/Pacific.
The primary endpoint of the BEACON study will be overall survival, and secondary endpoints will include progression-free survival and objective tumor response rates. Secondary endpoints also include clinical benefit rate, duration of response, PK data, safety profiles, quality-of-life measurements, and pharmacoeconomic implications.
Besides, exploratory objectives of the study will include collecting specific biomarker data to correlate with objective tumor response rates, progression-free survival, overall survival and selected toxicities.
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