Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

Phase 3

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Karenitecin; Drug: Topotecan

• Registration Number: NCT00477282
• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.

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

Not available

Study Timeline

• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-23
• Study Start: 2007-08
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 509

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Karenitecin	Karenitecin	-
Topotecan	Topotecan	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	baseline to measured progressive disease

Secondary Outcome Measures

Name	Time	Method
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
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 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