The POLEN Study “A preoperative window-opportunity”, multicenter, pharmacokinetic-pharmacodynamic study to evaluate the inhibitory effects of single agent AZD2281 (Olaparib) in patients with early-stage endometrial carcinoma” finalized its recruitment last 7th May 2018.
The primary objective of this study is to identify, the antitumoral biological efficacy, by measuring in human tumor samples, biomarker changes associated to short exposure to AZD2281 as potential predictors of activity in Endometrial Carcinoma (EC). This is an exploratory study with a biological primary endpoint. 10 Spanish sites have participated and a total of 49 patients have been recruited (36 treated and 13 Screening Failure) since February 2016. It’s been a long journey with many difficulties but the perseverance and effort of the site investigators and collaborators from the Oncology, Gynecology and Pathological Anatomy Services have been key to achieve it.
Thank you very much to all of them and specially to the H. Reina Sofia de Córdoba (Dr. Mª Jesús Rubio), H. Ramón y Cajal (Dr. Eva Guerra and Dr Alfonso Cortés), Instituto Valenciano de Oncología (Dr. Ignacio Romero) and H. Clínico San Carlos (Dr. Casado) as top recruiters. The research team was supported by an unrestricted fellowship from Astra Zeneca. From now on, we will focus in the analysis of the results with an expected database lock by end of July 2018 and Final Study Report by end of October 2018.