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 AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupCytotoxic Antibiotics and Related SubstancesChemical SubgroupAnthracyclines and Related SubstancesCondition StudiedNeoplasms, Ovarian
Sponsor Protocol Number30-49Enrollment481Data PartnerJohnson & Johnson% Female100%Mean/Median Age (Years)60% WhiteN/A

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

Approved Data Requests Associated with this Trial

Disclaimer

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