Study Phase 3

A Phase 3, Randomized, Open-Label, Comparative Study of DOXIL/CAELYX® versus Topotecan HCl in Patients with Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Trial Information

Generic NameDoxorubicin hydrochlorideProduct NameDOXIL®Therapeutic AreaCancers and Other NeoplasmsEnrollment481% Female100%% WhiteN/A
Product ClassOncology - AntibioticSponsor Protocol Number30-49Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, OvarianMean/Median Age (Years)60

Supporting Documentation

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

Protocol with Amendments included in Appendix 1.1 of the CSR
Statistical Analysis Plan included in Appendix 2.1 of the CSR

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