Last April 2020, MEDSIR submitted to the AEMPS and the CEIm the ZZ-First study: "A randomized phase II trial to evaluate the antitumor activity of Enzalutamide and Talazoparib (PF-06944076) for the treatment of metastatic hormone-naïve prostate cancer".
The ZZ-First study is intended for male patients with metastatic prostate cancer who have not received previous systemic treatment for the metastatic stage with the main objective to evaluate the antitumor activity of talazoparib (PF-06944076) in combination with enzalutamide and ADT in patients with Metastatic Hormone–Naïve Prostate Cancer (mHNPC).
This multicenter, open-label, randomized, two-arm, phase II clinical trial is focused in to explore the possibility to expand the population benefiting from PARP inhibition beyond patients with DDR genomic defects, and prolong the clinical benefit from patients receiving enzalutamide, delaying emergence of clinical progression. For this purpose, several tissues and blood samples are requested throughout the study to perform translational studies to assess the correlation between molecular and transcriptomic signatures of deoxyribonucleic acid (DNA) repair function and antitumor activity in this population.
This proposal has been presented by MEDSIR to Pfizer with Dr. Joaquín Mateo from Vall d'Hebron Institute of Oncology (VHIO) as Principal Investigator. We will also have the collaboration of Astellas Pharma.
It is expected to recruit an overall of 54 patients in 9 Spanish sites with an accrual period of 17 months. The enrollment is planned to be opened in the next months.
From MEDSIR, we would like to thank all the study investigators for their interest in participating in the ZZ-First study.
Author: Javier Clemente