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Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Karenitecin
Topotecan
Sponsored by
BioNumerik Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian, Cancer, Advanced Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Karenitecin

Topotecan

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall Survival
Incidence of Anemia
Incidence of Neutropenia
Incidence of Thrombocytopenia

Full Information

First Posted
May 21, 2007
Last Updated
March 10, 2020
Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience
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1. Study Identification

Unique Protocol Identification Number
NCT00477282
Brief Title
Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian, Cancer, Advanced Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Karenitecin
Arm Type
Experimental
Arm Title
Topotecan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Karenitecin
Other Intervention Name(s)
BNP1350
Intervention Description
Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
baseline to measured progressive disease
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
baseline to date of death from any cause
Title
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.
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
City
Oploe
ZIP/Postal Code
45-060
Country
Poland
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Bucharest
ZIP/Postal Code
500098
Country
Romania
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
City
Craiova
ZIP/Postal Code
200535
Country
Romania
City
Iasi
ZIP/Postal Code
700106
Country
Romania
City
Oradea
ZIP/Postal Code
410159
Country
Romania
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
City
Suceava County
ZIP/Postal Code
720237
Country
Romania
City
Targu Mures
ZIP/Postal Code
540072
Country
Romania
City
Ulan-Ude
State/Province
Rep. Of Buryatiya
ZIP/Postal Code
670047
Country
Russian Federation
City
Isvesk
State/Province
Republic Of Udmurtia
ZIP/Postal Code
426009
Country
Russian Federation
City
Engels
State/Province
Saratov Region
ZIP/Postal Code
413115
Country
Russian Federation
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
City
Birobidjan
ZIP/Postal Code
679016
Country
Russian Federation
City
Khabarovsk
ZIP/Postal Code
680042
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
City
Magnitogorsk
ZIP/Postal Code
455001
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
City
Petrozavodsk
ZIP/Postal Code
185007
Country
Russian Federation
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
City
Stavropol
ZIP/Postal Code
355047
Country
Russian Federation
City
Syktyvkar
ZIP/Postal Code
167904
Country
Russian Federation
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
City
Vladimir
ZIP/Postal Code
600020
Country
Russian Federation
City
Vladivostok
ZIP/Postal Code
690105
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/ovariancancer.html
Description
MedlinePlus related topic: Ovarian Cancer

Learn more about this trial

Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

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