Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

March 10, 2020 updated by: BioNumerik Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1082
      • Budapest, Hungary, 1032
      • Gyor, Hungary, 9024
  • Lithuania
      • Kaunas, Lithuania, 50009
      • Klaipeda, Lithuania, 92288
  • Poland
      • Elblag, Poland, 82-300
      • Krakow, Poland, 31-501
      • Lublin, Poland, 20-090
      • Olsztyn, Poland, 10-228
      • Oploe, Poland, 45-060
      • Poznan, Poland, 61-866
      • Poznan, Poland, 60-535
      • Szczecin, Poland, 70-111
      • Tarnow, Poland, 33-100
  • Romania
      • Bucharest, Romania, 022328
      • Bucharest, Romania, 500098
      • Cluj Napoca, Romania, 400015
      • Craiova, Romania, 200535
      • Iasi, Romania, 700106
      • Oradea, Romania, 410159
      • Sibiu, Romania, 550245
      • Suceava County, Romania, 720237
      • Targu Mures, Romania, 540072
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
      • Birobidjan, Russian Federation, 679016
      • Khabarovsk, Russian Federation, 680042
      • Krasnodar, Russian Federation, 350040
      • Kursk, Russian Federation, 305035
      • Magnitogorsk, Russian Federation, 455001
      • Nizhny Novgorod, Russian Federation, 603109
      • Novosibirsk, Russian Federation, 630108
      • Orenburg, Russian Federation, 460021
      • Petrozavodsk, Russian Federation, 185007
      • Pyatigorsk, Russian Federation, 357502
      • Ryazan, Russian Federation, 390011
      • Sochi, Russian Federation, 354057
      • St. Petersburg, Russian Federation, 191104
      • St. Petersburg, Russian Federation, 198255
      • Stavropol, Russian Federation, 355047
      • Syktyvkar, Russian Federation, 167904
      • Tambov, Russian Federation, 392013
      • Ufa, Russian Federation, 450054
      • Vladimir, Russian Federation, 600020
      • Vladivostok, Russian Federation, 690105
    • Rep. Of Buryatiya
      • Ulan-Ude, Rep. Of Buryatiya, Russian Federation, 670047
    • Republic Of Udmurtia
      • Isvesk, Republic Of Udmurtia, Russian Federation, 426009
    • Saratov Region
      • Engels, Saratov Region, Russian Federation, 413115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Hycamtin
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 Names:
  • BNP1350

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: baseline to measured progressive disease
baseline to measured progressive disease

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: baseline to date of death from any cause
baseline to date of death from any cause
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.
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 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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioNumerik Pharmaceuticals, Inc.

Collaborators

Crown Bioscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTN32313R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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