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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Ovarian Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Ebersberg, Bayern, Germany, 85567
      • Praxis und Tagesklinik für gynäkologische Onkologie
  • Lower Saxony
    • Rotenburg, Lower Saxony, Germany, 27356
      • Diakoniekrankenhaus, Gynäkologie und Geburtshilfe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

hospitales and medical practices in Germany

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Yondelis-Pegylated liposomal Doxorubicin; 30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability data of the study therapy	Number of patients with adverse events	during Yondelis-PLD-therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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
Treatment duration	Time between first and last cycle of each patient	during Yondelis-PLD-therapy
Observation of the number of the therapy cycles applied	Number of applied therapy cycles	during Yondelis-PLD-therapy
Time to next treatment	Date from last Yondelis-PLD-treatment to date of next treatment	1 Year after last Yondelis-PLD-Therapy
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
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

Collaborators and Investigators

• Sponsor: PharmaMar, Spain
• Investigators: Study Chair: Ingo Runnebaum, Prof. Dr., Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: OvaYond

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED