An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Recurrent Ovarian Cancer Clinical Trial

— NIS-OvaYond  

Official title:

An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869400
• Other study ID #: OvaYond
• Status: Completed
• First received: May 15, 2013
• Last updated: April 4, 2018
• Start date: April 2013
• Est. completion date: February 2017

Study information

• Verified date: April 2018
• Source: PharmaMar, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Recurrent Ovarian Cancer

Locations

Country	Name	City	State
Germany	Praxis und Tagesklinik für gynäkologische Onkologie	Ebersberg	Bayern
Germany	Diakoniekrankenhaus, Gynäkologie und Geburtshilfe	Rotenburg	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
PharmaMar, Spain

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability data of the study therapy	Number of patients with adverse events	during Yondelis-PLD-therapy
Secondary	"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates	Number of patients with CR, PR, SD as best response	till one year after last date of Yondelis-PLD-therapy
Secondary	Treatment duration	Time between first and last cycle of each patient	during Yondelis-PLD-therapy
Secondary	Observation of the number of the therapy cycles applied	Number of applied therapy cycles	during Yondelis-PLD-therapy
Secondary	Time to next treatment	Date from last Yondelis-PLD-treatment to date of next treatment	1 Year after last Yondelis-PLD-Therapy
Secondary	Progression free survival	Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application	till one year after last date of Yondelis-PLD-therapy
Secondary	Duration of response	Time in months from first assessment of CR or PR until the first date of PD or death.	till one year after last date of Yondelis-PLD-therapy