An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
NIS-OvaYond
An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
1 other identifier
observational
83
1 country
2
Brief Summary
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population. Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials. This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 6, 2018
April 1, 2018
3.7 years
May 15, 2013
April 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
safety and tolerability data of the study therapy
Number of patients with adverse events
during Yondelis-PLD-therapy
Secondary Outcomes (6)
"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
till one year after last date of Yondelis-PLD-therapy
Treatment duration
during Yondelis-PLD-therapy
Observation of the number of the therapy cycles applied
during Yondelis-PLD-therapy
Time to next treatment
1 Year after last Yondelis-PLD-Therapy
Progression free survival
till one year after last date of Yondelis-PLD-therapy
- +1 more secondary outcomes
Study Arms (1)
Yondelis-Pegylated liposomal Doxorubicin
30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks
Eligibility Criteria
hospitales and medical practices in Germany
You may qualify if:
- Women age \>18, no upper limit
- Patients with relapsed platinum-sensitive ovarian cancer
You may not qualify if:
- According to summary of product characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaMar, Spainlead
Study Sites (2)
Praxis und Tagesklinik für gynäkologische Onkologie
Ebersberg, Bavaria, 85567, Germany
Diakoniekrankenhaus, Gynäkologie und Geburtshilfe
Rotenburg (Wümme), Lower Saxony, 27356, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ingo Runnebaum, Prof. Dr.
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2013
First Posted
June 5, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
April 6, 2018
Record last verified: 2018-04