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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00477282 |
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Date of registration:
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21/05/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
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Scientific title:
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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 |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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509 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00477282 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Hungary
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Lithuania
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Poland
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Romania
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Russian Federation
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Turkey
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United States
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Drug: Karenitecin
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Drug: Topotecan
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Primary Outcome(s)
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Progression Free Survival
[Time Frame: baseline to measured progressive disease]
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Secondary Outcome(s)
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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]
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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]
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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.]
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Overall Survival
[Time Frame: baseline to date of death from any cause]
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Secondary ID(s)
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KTN32313R
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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