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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by PharmaMar, Spain
Sponsor:
Information provided by (Responsible Party):
PharmaMar, Spain
ClinicalTrials.gov Identifier:
NCT01869400
First received: May 15, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition
Recurrent Ovarian Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by PharmaMar, Spain:

Primary Outcome Measures:
  • safety and tolerability data of the study therapy [ Time Frame: during Yondelis-PLD-therapy ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events


Secondary Outcome Measures:
  • "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 ] [ Designated as safety issue: No ]
    Number of patients with CR, PR, SD as best response

  • Treatment duration [ Time Frame: during Yondelis-PLD-therapy ] [ Designated as safety issue: No ]
    Time between first and last cycle of each patient

  • Observation of the number of the therapy cycles applied [ Time Frame: during Yondelis-PLD-therapy ] [ Designated as safety issue: No ]
  • Time to next treatment [ Time Frame: 1 Year after last Yondelis-PLD-Therapy ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: till one year after last date of Yondelis-PLD-therapy ] [ Designated as safety issue: No ]
    Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application

  • Duration of response [ Time Frame: till one year after last date of Yondelis-PLD-therapy ] [ Designated as safety issue: No ]
    Time in months from first assessment of CR or PR until the first date of PD or death.


Estimated Enrollment: 180
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Yondelis-Pegylated liposomal Doxorubicin
30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

hospitales and medical practices in Germany

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869400

Locations
Germany
Praxis und Tagesklinik für gynäkologische Onkologie Recruiting
Ebersberg, Bayern, Germany, 85567
Contact: Isolde Gröll de Rivera, Dr. med.       isolde.groell@gyn-grafing.de   
Principal Investigator: Isolde Gröll de Rivera, Dr. med.         
Diakoniekrankenhaus, Gynäkologie und Geburtshilfe Recruiting
Rotenburg, Lower Saxony, Germany, 27356
Contact: Tobias Hesse, Dr. med.       hesse@diako-online.de   
Principal Investigator: Tobias Hesse, Dr. med.         
Sponsors and Collaborators
PharmaMar, Spain
Investigators
Study Chair: Ingo Runnebaum, Prof. Dr. Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
  More Information

No publications provided

Responsible Party: PharmaMar, Spain
ClinicalTrials.gov Identifier: NCT01869400     History of Changes
Other Study ID Numbers: OvaYond
Study First Received: May 15, 2013
Last Updated: September 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Trabectedin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014