Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

Last updated: March 10, 2020
Sponsor: BioNumerik Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Pelvic Cancer

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT00477282
KTN32313R
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or otherserious underlying medical condition not compatible with study entry.

  • Have a life expectancy < 3 months

  • Received prior treatment with a camptothecin (topotecan, CPT-11, or investigationalcamptothecins).

  • 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 Design

Total Participants: 509
Study Start date:
August 01, 2007
Estimated Completion Date:
June 30, 2013

Connect with a study center

  • Budapest, 1082
    Hungary

    Site Not Available

  • Gyor, 9024
    Hungary

    Site Not Available

  • Kaunas, 50009
    Lithuania

    Site Not Available

  • Klaipeda, 92288
    Lithuania

    Site Not Available

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    Bialystok, 15-027
    Poland

    Site Not Available

  • Elblag, 82-300
    Poland

    Site Not Available

  • Krakow, 31-501
    Poland

    Site Not Available

  • Lublin, 20-090
    Poland

    Site Not Available

  • Olsztyn, 10-228
    Poland

    Site Not Available

  • Oploe, 45-060
    Poland

    Site Not Available

  • Poznan, 60-535
    Poland

    Site Not Available

  • Szczecin, 70-111
    Poland

    Site Not Available

  • Tarnow, 33-100
    Poland

    Site Not Available

  • Bucharest, 022328
    Romania

    Site Not Available

  • Cluj Napoca, 400015
    Romania

    Site Not Available

  • Craiova, 200535
    Romania

    Site Not Available

  • Iasi, 700106
    Romania

    Site Not Available

  • Oradea, 410159
    Romania

    Site Not Available

  • Sibiu, 550245
    Romania

    Site Not Available

  • Suceava County, 720237
    Romania

    Site Not Available

  • Targu Mures, 540072
    Romania

    Site Not Available

  • Ulan-Ude, Rep. Of Buryatiya 670047
    Russian Federation

    Site Not Available

  • Isvesk, Republic Of Udmurtia 426009
    Russian Federation

    Site Not Available

  • Engels, Saratov Region 413115
    Russian Federation

    Site Not Available

  • Arkhangelsk, 163045
    Russian Federation

    Site Not Available

  • Birobidjan, 679016
    Russian Federation

    Site Not Available

  • Khabarovsk, 680042
    Russian Federation

    Site Not Available

  • Krasnodar, 350040
    Russian Federation

    Site Not Available

  • Kursk, 305035
    Russian Federation

    Site Not Available

  • Magnitogorsk, 455001
    Russian Federation

    Site Not Available

  • Nizhny Novgorod, 603109
    Russian Federation

    Site Not Available

  • Novosibirsk, 630108
    Russian Federation

    Site Not Available

  • Orenburg, 460021
    Russian Federation

    Site Not Available

  • Petrozavodsk, 185007
    Russian Federation

    Site Not Available

  • Pyatigorsk, 357502
    Russian Federation

    Site Not Available

  • Ryazan, 390011
    Russian Federation

    Site Not Available

  • Sochi, 354057
    Russian Federation

    Site Not Available

  • St. Petersburg, 198255
    Russian Federation

    Site Not Available

  • Stavropol, 355047
    Russian Federation

    Site Not Available

  • Syktyvkar, 167904
    Russian Federation

    Site Not Available

  • Tambov, 392013
    Russian Federation

    Site Not Available

  • Ufa, 450054
    Russian Federation

    Site Not Available

  • Vladimir, 600020
    Russian Federation

    Site Not Available

  • Vladivostok, 690105
    Russian Federation

    Site Not Available

  • empty

    Voorhees, New Jersey 08043
    United States

    Site Not Available

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