Zentalis (ZNTL) Pharmaceuticals announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer, PROC. As previously disclosed, the Company aligned with the U.S. Food and Drug Administration, FDA, on the design of DENALI Part 2, which allows for seamless enrollment in the two parts of the trial: Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of approximately 30 patients at each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2. Part 2b is designed to enroll approximately 70 additional patients at the selected dose, which will be informed by the Part 2a results, subject to FDA feedback.
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