NCT00477282

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
Completed

Started Aug 2007

Typical duration for phase_3 ovarian-cancer

Geographic Reach
5 countries

48 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

5.8 years

First QC Date

May 21, 2007

Last Update Submit

March 10, 2020

Conditions

Ovarian Cancer

Keywords

OvarianCancerAdvanced Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    baseline to measured progressive disease

Secondary Outcomes (4)

  • Overall Survival

    baseline to date of death from any cause

  • Incidence of Anemia

    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

    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

    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

Study Arms (2)

Karenitecin

EXPERIMENTAL
Drug: Karenitecin

Topotecan

ACTIVE COMPARATOR
Drug: Topotecan

Interventions

KarenitecinDRUG

Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)

Also known as: BNP1350
Karenitecin
TopotecanDRUG

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)

Also known as: Hycamtin
Topotecan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Unknown Facility

Budapest, 1032, Hungary

Location

Unknown Facility

Budapest, 1082, Hungary

Location

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Budapest, 1088, Hungary

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Győr, 9024, Hungary

Location

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Kaunas, 50009, Lithuania

Location

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Klaipėda, 92288, Lithuania

Location

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Elblag, 82-300, Poland

Location

Unknown Facility

Krakow, 31-501, Poland

Location

Unknown Facility

Lublin, 20-090, Poland

Location

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Olsztyn, 10-228, Poland

Location

Unknown Facility

Oploe, 45-060, Poland

Location

Unknown Facility

Poznan, 60-535, Poland

Location

Unknown Facility

Poznan, 61-866, Poland

Location

Unknown Facility

Szczecin, 70-111, Poland

Location

Unknown Facility

Tarnów, 33-100, Poland

Location

Unknown Facility

Bucharest, 022328, Romania

Location

Unknown Facility

Bucharest, 500098, Romania

Location

Unknown Facility

Cluj-Napoca, 400015, Romania

Location

Unknown Facility

Craiova, 200535, Romania

Location

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Iași, 700106, Romania

Location

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Oradea, 410159, Romania

Location

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Sibiu, 550245, Romania

Location

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Suceava County, 720237, Romania

Location

Unknown Facility

Târgu Mureş, 540072, Romania

Location

Unknown Facility

Ulan-Ude, Rep. of Buryatiya, 670047, Russia

Location

Unknown Facility

Engel's, Saratov Oblast, 413115, Russia

Location

Unknown Facility

Isvesk, Udmurtiya Republic, 426009, Russia

Location

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Arkhangelsk, 163045, Russia

Location

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Birobidzhan, 679016, Russia

Location

Unknown Facility

Khabarovsk, 680042, Russia

Location

Unknown Facility

Krasnodar, 350040, Russia

Location

Unknown Facility

Kursk, 305035, Russia

Location

Unknown Facility

Magnitogorsk, 455001, Russia

Location

Unknown Facility

Nizhny Novgorod, 603109, Russia

Location

Unknown Facility

Novosibirsk, 630108, Russia

Location

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Orenburg, 460021, Russia

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Petrozavodsk, 185007, Russia

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Pyatigorsk, 357502, Russia

Location

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Ryazan, 390011, Russia

Location

Unknown Facility

Saint Petersburg, 191104, Russia

Location

Unknown Facility

Saint Petersburg, 198255, Russia

Location

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Sochi, 354057, Russia

Location

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Stavropol, 355047, Russia

Location

Unknown Facility

Syktyvkar, 167904, Russia

Location

Unknown Facility

Tambov, 392013, Russia

Location

Unknown Facility

Ufa, 450054, Russia

Location

Unknown Facility

Vladimir, 600020, Russia

Location

Unknown Facility

Vladivostok, 690105, Russia

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Interventions

cositecanTopotecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 23, 2007

Study Start

August 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

RO(9)HU(4)LI(2)RU(24)PL(9)