An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
NCT ID: NCT01869400
Last Updated: 2018-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
83 participants
OBSERVATIONAL
2013-04-30
2017-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Yondelis-Pegylated liposomal Doxorubicin
30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with relapsed platinum-sensitive ovarian cancer
* Before inclusion in the NIS written informed consent must be given
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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PharmaMar, Spain
INDUSTRY
Responsible Party
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Principal Investigators
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Ingo Runnebaum, Prof. Dr.
Role: STUDY_CHAIR
Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
Locations
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Praxis und Tagesklinik für gynäkologische Onkologie
Ebersberg, Bavaria, Germany
Diakoniekrankenhaus, Gynäkologie und Geburtshilfe
Rotenburg (Wümme), Lower Saxony, Germany
Countries
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Other Identifiers
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OvaYond
Identifier Type: -
Identifier Source: org_study_id
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