The San Diego-based company has been conducting a phase 1 and two phase 2 studies on azenosertib, a drug candidate for advanced solid tumors and hematologic malignancies. Two recent deaths in one of the phase 2 studies, which was targeting ovarian cancer, have led to a partial clinical hold.
The deaths are suspected to be related to sepsis, the drugmaker said in a news release.
The other phase 2 study is investigating how azenosertib affects uterine serous carcinoma, and the phase 1 trial is testing the therapy in solid tumors. More than 500 patients have received the experimental medicine.
“Patient safety is our top priority and any deaths that occur in the setting of clinical trials are unfortunate,” Kimberly Blackwell, MD, CEO of Zentalis, said in the release. “We are working closely with the FDA to resolve this partial clinical hold as quickly as possible.”
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
