Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Karenitecin
* Drug: Topotecan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Karenitecin<br> | Drug: Karenitecin<br>* Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)<br>* Other names: BNP1350;|
| Active Comparator: Topotecan<br> | Drug: Topotecan<br>* 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)<br>* Other names: Hycamtin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | baseline to measured progressive disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | baseline to date of death from any cause | 
| Incidence of Anemia |  | 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. | 
| Incidence of Neutropenia |  | 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 | 
| Incidence of Thrombocytopenia |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian, Cancer, Advanced Ovarian Cancer