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Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00477282
First received: May 21, 2007
Last updated: August 31, 2012
Last verified: April 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 Study Completion Date: November 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Karenitecin 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
Active Comparator: Topotecan 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

  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

  Show 48 Study Locations
Sponsors and Collaborators
BioNumerik Pharmaceuticals, Inc.
  More Information

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

No publications provided

Responsible Party: BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00477282     History of Changes
Other Study ID Numbers: KTN32313R
Study First Received: May 21, 2007
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioNumerik Pharmaceuticals, Inc.:
Ovarian
Cancer
Advanced Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Neoplasms by Histologic Type
Topotecan
Camptothecin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013