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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869400
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Other
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
Actual Study Start Date : April 2013
Primary Completion Date : December 2016
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Trabectedin
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. safety and tolerability data of the study therapy [ Time Frame: during Yondelis-PLD-therapy ]
    Number of patients with adverse events

Secondary Outcome Measures :
  1. "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 ]
    Number of patients with CR, PR, SD as best response

  2. Treatment duration [ Time Frame: during Yondelis-PLD-therapy ]
    Time between first and last cycle of each patient

  3. Observation of the number of the therapy cycles applied [ Time Frame: during Yondelis-PLD-therapy ]
  4. Time to next treatment [ Time Frame: 1 Year after last Yondelis-PLD-Therapy ]
  5. Progression free survival [ Time Frame: till one year after last date of Yondelis-PLD-therapy ]
    Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application

  6. Duration of response [ Time Frame: till one year after last date of Yondelis-PLD-therapy ]
    Time in months from first assessment of CR or PR until the first date of PD or death.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospitales and medical practices in Germany

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869400

Praxis und Tagesklinik für gynäkologische Onkologie
Ebersberg, Bayern, Germany, 85567
Diakoniekrankenhaus, Gynäkologie und Geburtshilfe
Rotenburg, Lower Saxony, Germany, 27356
Sponsors and Collaborators
PharmaMar, Spain
Study Chair: Ingo Runnebaum, Prof. Dr. Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
More Information

Responsible Party: PharmaMar, Spain
ClinicalTrials.gov Identifier: NCT01869400     History of Changes
Other Study ID Numbers: OvaYond
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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