Study Phase 2

A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

Trial Information

Generic NameTrabectedinProduct NameYONDELIS®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupPlant Alkaloids and Other Natural ProductsChemical SubgroupOther Plant Alkaloids and Natural ProductsCondition StudiedSolid Tumor
Sponsor Protocol NumberET743-OVC-1001Enrollment75Data PartnerJohnson & Johnson% Female68.0%Mean/Median Age (Years)50.1% White68.0%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.