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Ovarian CancerPhase 3NCT00477282

Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

A Phase 3 study testing Karenitecin and Topotecan in people with Ovarian Cancer, run by BioNumerik Pharmaceuticals, Inc. at 48 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Karenitecin and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
509 participants
Where
48 sitesin 5 countries
Study dates
Aug 2007to Jun 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

48 sites in 5 countries.

48 sites in 5 countries

Russia24 sites

  • Study site

    Arkhangelsk, 163045

  • Study site

    Birobidzhan, 679016

  • Study site

    Engel's, Saratov Oblast, 413115

  • Study site

    Isvesk, Udmurtiya Republic, 426009

  • Study site

    Khabarovsk, 680042

  • Study site

    Krasnodar, 350040

  • Study site

    Kursk, 305035

  • Study site

    Magnitogorsk, 455001

  • Study site

    Nizhny Novgorod, 603109

  • Study site

    Novosibirsk, 630108

  • Study site

    Orenburg, 460021

  • Study site

    Petrozavodsk, 185007

  • Study site

    Pyatigorsk, 357502

  • Study site

    Ryazan, 390011

  • Study site

    Saint Petersburg, 191104

  • Study site

    Saint Petersburg, 198255

  • Study site

    Sochi, 354057

  • Study site

    Stavropol, 355047

  • Study site

    Syktyvkar, 167904

  • Study site

    Tambov, 392013

  • Study site

    Ufa, 450054

  • Study site

    Ulan-Ude, Rep. of Buryatiya, 670047

  • Study site

    Vladimir, 600020

  • Study site

    Vladivostok, 690105

Other trials in Russia

Poland9 sites

  • Study site

    Elblag, 82-300

  • Study site

    Krakow, 31-501

  • Study site

    Lublin, 20-090

  • Study site

    Olsztyn, 10-228

  • Study site

    Oploe, 45-060

  • Study site

    Poznan, 60-535

  • Study site

    Poznan, 61-866

  • Study site

    Szczecin, 70-111

  • Study site

    Tarnów, 33-100

Other trials in Poland

Romania9 sites

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest, 500098

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Craiova, 200535

  • Study site

    Iași, 700106

  • Study site

    Oradea, 410159

  • Study site

    Sibiu, 550245

  • Study site

    Suceava County, 720237

  • Study site

    Târgu Mureş, 540072

Other trials in Romania

Hungary4 sites

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1088

  • Study site

    Győr, 9024

Other trials in Hungary

Lithuania2 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 92288

Other trials in Lithuania

About this study

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

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.

Conditions
Ovarian Cancer
Being tested
Karenitecin, Topotecan
Keywords
Ovarian, Cancer, Advanced Ovarian Cancer
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KarenitecinDrug

    Also called BNP1350

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

  • TopotecanDrug

    Also called Hycamtin

    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)

Study groups in NCT00477282
Study groupRoleWhat they receive
KarenitecinExperimentalNot described
Receives: Drug: Karenitecin
TopotecanActive comparatorNot described
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Measured: baseline to measured progressive disease

Secondary outcomes (4)

  1. Overall Survival

    Measured: baseline to date of death from any cause

  2. Incidence of Anemia

    Measured: 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

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00477282
Sponsor's protocol ID
KTN32313R
Status last verified
Mar 2020
First submitted
21 May 2007
Last updated
12 Mar 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Karenitecin and Topotecan in people with Ovarian Cancer, run by BioNumerik Pharmaceuticals, Inc. at 48 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Russia, Poland, Romania, Hungary, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: baseline to measured progressive disease). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00477282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.

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