Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer


Tracking Information

Start Date  ICMJEAugust 2007
Estimated Primary Completion DateDecember 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 HistoryComplete list of historical versions of study NCT00477282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 11, 2008)
  • Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Incidence of Anemia [ Time Frame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration. ] [ Designated as safety issue: Yes ]
  • Incidence of Neutropenia [ Time Frame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration ] [ Designated as safety issue: Yes ]
  • Incidence of Thrombocytopenia [ Time Frame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: May 21, 2007)
  • Overall Survival
  • Reduced incidence of anemia
  • Reduced incidence of neutropenia
  • Reduced incidence of thrombocytopenia

Descriptive Information

Brief Title  ICMJEKarenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
Official Title  ICMJEA 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEOvarian Cancer
Intervention  ICMJE
  • Drug: Karenitecin
    Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
    Other Name: BNP1350
  • Drug: Topotecan
    Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days)
    Other Name: Hycamtin
Study Arms / Comparison Groups
  • Karenitecin: Experimental
    Intervention: Drug: Karenitecin
  • Topotecan: Active Comparator
    Intervention: Drug: Topotecan

Recruitment Information

Estimated Enrollment  ICMJE500
Completion Date 
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed diagnosis of stage III or IV epithelial ovarian cancer
  • Have cancer that is resistant to platinum/taxane-based chemotherapy regimens
  • Have measurable, progressive disease
  • Have an ECOG PS ≤ 2

Exclusion Criteria:

  • Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
  • Have a life expectancy < 3 months
  • Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
  • Received prior treatment with any platinum agent other than cisplatin or carboplatin.
  • Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
GenderFemale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Study Director (BioNumerik Pharmaceuticals Inc)210-614-1701
Location Countries  ICMJEUnited States,   Hungary,   Lithuania,   Poland,   Romania,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00477282
Responsible PartyBioNumerik (Chief Executive Officer), Bionumerik
Study ID Numbers  ICMJEKTN32313R
Study Sponsor  ICMJEBioNumerik Pharmaceuticals, Inc.
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByBioNumerik Pharmaceuticals, Inc.