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Completed

NCT Number: NCT00477282

Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

karenitecin

Drug

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 names: BNP1350

Topotecan

Drug

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 names: Hycamtin

Primary outcomes

  1. Progression Free Survival

    Time frame: baseline to measured progressive disease

Secondary outcomes

  1. Overall Survival

    Time frame: baseline to date of death from any cause

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

BioNumerik Pharmaceuticals, Inc.

Industry

Collaborators

  • Crown Bioscience

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 23, 2007
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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