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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

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

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NCT Number

Not Available


Data Specification

Not Yet Available


Annotated CRF

Not Yet Available

Product Info

Generic Name
Doxorubicin hydrochloride
Product Name
DOXIL®
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
481
Product Class
Oncology - Antibiotic
Sponsor Protocol Number
30-49
Data Holder
Johnson & Johnson
Condition Studied
Neoplasms, Ovarian

Supporting Documentation

Analysis Datasets
Annotated Case Report Form (CRF)
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3
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

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.