Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
Tracking Information
Start Date ICMJE | August 2007 |
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Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: April 11, 2008) | Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: May 21, 2007) | Progression free survival |
Change History | Complete list of historical versions of study NCT00477282 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: April 11, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: May 21, 2007) |
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Descriptive Information
Brief Title ICMJE | Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer |
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Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Ovarian Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 500 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Hungary, Lithuania, Poland, Romania, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00477282 |
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Responsible Party | BioNumerik (Chief Executive Officer), Bionumerik |
Study ID Numbers ICMJE | KTN32313R |
Study Sponsor ICMJE | BioNumerik Pharmaceuticals, Inc. |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | BioNumerik Pharmaceuticals, Inc. |
Source: http://clinicaltrials.gov/