An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
Yondelis® (trabectedin) was approved (in combination with PLD) in the European community in
December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the
outcomes of study OVA-301, this non-interventional study will investigate the role of a
platinum-free treatment regimen in patients with progressive ovarian cancer relapsing > 6
months after completing previous platinum-based chemotherapy. In particular, this study aims
at collecting the "real-life" data with regard to the response and the influence of the
mentioned therapy on the "tumor related events", to objectify the value of palliative care.
Time Perspective: Prospective
safety and tolerability data of the study therapy
Number of patients with adverse events
Ingo Runnebaum, Prof. Dr.
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
Germany: Federal Institute for Drugs and Medical Devices