Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer - Full Text View

Sponsored by:	BioNumerik Pharmaceuticals, Inc.
Information provided by:	BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00477282

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Karenitecin Drug: Topotecan	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Topotecan hydrochloride Topotecan Karenitecin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	500
Study Start Date:	August 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Karenitecin: Experimental	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: Active Comparator	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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477282

Contacts

Contact: Study Director (BioNumerik Pharmaceuticals Inc)

210-614-1701

Show 46 Study Locations

Sponsors and Collaborators

BioNumerik Pharmaceuticals, Inc.

More Information

MedlinePlus related topic: Ovarian Cancer This link exits the ClinicalTrials.gov site

Responsible Party:	Bionumerik ( BioNumerik (Chief Executive Officer) )
Study ID Numbers:	KTN32313R
Study First Received:	May 21, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00477282
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission; Hungary: National Institute of Pharmacy; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Ministry of Health; Romania: National Medicines Agency; Russia: Ethics Committee; Russia: Pharmacological Committee, Ministry of Health; Turkey: Ethics Committee; Turkey: Ministry of Health

Keywords provided by BioNumerik Pharmaceuticals, Inc.:

Ovarian
Cancer
Advanced Ovarian Cancer

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Topotecan
Ovarian epithelial cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009