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

Pharma Mar

Status: Completed

Conditions: Recurrent Ovarian Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01869400

OvaYond

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

83 participants in 1 patient group

Yondelis-Pegylated liposomal Doxorubicin

Description:

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