An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
18 Years
N/A
Female
Recurrent Ovarian Cancer
Trial Information
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.
Inclusion Criteria:
- Women age >18, no upper limit
- Patients with relapsed platinum-sensitive ovarian cancer
- Before inclusion in the NIS written informed consent must be given
Exclusion Criteria:
- According to summary of product characteristics
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
safety and tolerability data of the study therapy
Outcome Description:
Number of patients with adverse events
Outcome Time Frame:
during Yondelis-PLD-therapy
Safety Issue:
Yes
Principal Investigator
Ingo Runnebaum, Prof. Dr.
Investigator Role:
Study Chair
Investigator Affiliation:
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
OvaYond
NCT ID:
NCT01869400
Start Date:
February 2013
Completion Date:
February 2016
Related Keywords:
- Recurrent Ovarian Cancer
- Ovarian Neoplasms
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