NOGGO ov50 – GRACE: registry of rucaparib in clinical practice – an evaluation of clinical experience in Germany

Objective This non-interventional trial is designed to develop and analyze real world efficacy data with rucaparib. Currently there is limited information available about the adherence to rucaparib. The primary objective of this study is to describe the rucaparib adherence rate. Second objectives are to evaluate the therapy management of rucaparib, the side effect management, and to estimate the rates of progression free survival after 6, 12 and 24 months and of treatment discontinuation due to treatment-emergent adverse events.

Methods This study will recruit 150 patients with histologically diagnosed platinum-sensitive relapsed high grade ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, that are eligible for rucaparib maintenance therapy according to Summary of Product Characteristics (SmPC). Throughout the study, individual patient data will be collected at baseline and every three months until disease progression or patient’s death whichever occurs first. To capture adherence of rucaparib therapy an adaption (according to the rucaparib therapy) of the “Essener Compliance Score” (ECS) is used. As of May 2022, 12 patients have been included in this study.

Interessenkonflikt

Ich erkläre als korrespondierender Autor, dass ich oder einer bzw. mehrere meiner Ko-Autoren während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten:

Interessenkonflikt Details Jalid Sehouli: Research Funding: Roche Pharma, AstraZeneca, Bayer, Clovis, GlaxoSmith, Lilly, Tesaro;

Honorary: Tesaro, GlaxoSmith, PharmaMar, AstraZeneca, Clovis, Bayer, Roche PharmaMar, Vifor Pharma, Hexal AG, Novartis Pharma;

Consulting: Tesaro, Merck /Pfizer, PharmaMar, Clovis Oncology, AstraZeneca, Roche Pharma; GlaxoSmith, MSD, Eisai, Novocure, Oncoinvent

Elena Ioana Braicu:

Honorar (persönlich): MSD, AstraZeneca, GSK, CLOVIS, RochePharma;

Consulting/ Advisory (persönlich): MSD, AstraZeneca, GSK, CLOVIS,NOGGO;

Research Funding (Institution): Bayer, MSD, Roche Diagnostic, AstraZeneca;

Reisekostenerstattungen (persönlich): Clovis, Roche

Martin Peters:

Sponsoring: Amgen, AstraZeneca, Celegene, Novartis, Pfizer, Roche, Teva;

Beratergremium: Novartis;

Vortragshonorar: Roche

Publikationsverlauf

Artikel online veröffentlicht:
11. Oktober 2022