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A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer
The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Budapest, Hungary
Budapest, Hungary
Budapest, Hungary
Győr, Hungary
Kaunas, Lithuania
Klaipėda, Lithuania
Elblag, Poland
Krakow, Poland
Lublin, Poland
Olsztyn, Poland
Start Date
August 1, 2007
Primary Completion Date
June 1, 2013
Completion Date
June 1, 2013
Last Updated
March 12, 2020
509
ACTUAL participants
Karenitecin
DRUG
Topotecan
DRUG
Lead Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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