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NCT01869400: NIS-OvaYond

An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Completed Last updated 4 April 2018
What this trial tests

trial in Recurrent Ovarian Cancer in 83 participants. Completed in 1 February 2017.

Timeline
1 April 2013
Primary endpoint
1 December 2016
1 February 2017

Quick facts

Lead sponsorPharmaMar, Spain
StatusCompleted
Study typeOBSERVATIONAL
Enrollment83
Start date1 April 2013
Primary completion1 December 2016
Estimated completion1 February 2017
Sites2 locations across Germany

Conditions studied

Sponsor

PharmaMar, Spain

Who can join

18 and older, female only, with Recurrent Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study.
    Runnebaum IB, Reichert D, Ringsdorf U, Kuther M, et al · · 2018 · cited 6× · PMID 29623421 · DOI 10.1007/s00432-018-2637-1
  2. Combinational use of trabectedin and pegylated liposomal doxorubicin for recurrent ovarian cancer: a meta-analysis of phase III randomized controlled trials.
    Li C, Qiao S, Kang M, Gao X, et al · · 2023 · cited 3× · PMID 38186978

Verify or expand the search:

Other recruiting trials for Recurrent Ovarian Cancer

Currently open trials in the same condition.

Other PharmaMar, Spain trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01869400.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing