Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477282
• Other study ID #: KTN32313R
• Status: Completed
• Phase: Phase 3
• Start date: August 2007
• Est. completion date: June 2013

Study information

• Verified date: March 2020
• Source: BioNumerik Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BioNumerik Pharmaceuticals, Inc.	Crown Bioscience, Inc. became karenitecin IND 057250 Sponsor on April 8, 2019

Countries where clinical trial is conducted

Hungary,  Lithuania,  Poland,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		baseline to measured progressive disease
Secondary	Overall Survival		baseline to date of death from any cause
Secondary	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.
Secondary	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
Secondary	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

External Links

•   MedlinePlus related topic: Ovarian Cancer