Overview

This trial is active, not recruiting.

Condition recurrent ovarian cancer
Sponsor PharmaMar, Spain
Start date February 2013
End date December 2016
Trial size 180 participants
Trial identifier NCT01869400, OvaYond

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks

Primary Outcomes

Measure
safety and tolerability data of the study therapy
time frame: during Yondelis-PLD-therapy

Secondary Outcomes

Measure
"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
time frame: till one year after last date of Yondelis-PLD-therapy
Treatment duration
time frame: during Yondelis-PLD-therapy
Observation of the number of the therapy cycles applied
time frame: during Yondelis-PLD-therapy
Time to next treatment
time frame: 1 Year after last Yondelis-PLD-Therapy
Progression free survival
time frame: till one year after last date of Yondelis-PLD-therapy
Duration of response
time frame: till one year after last date of Yondelis-PLD-therapy

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by PharmaMar, Spain.