Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
NCT ID: NCT01630018
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2011-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Topotecan
Topotecan
Topotecan
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Camtobell
Belotecan
Belotecan
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Interventions
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Topotecan
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Belotecan
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological or cytological diagnosis of AOC
* Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy
* Measurable disease defined by RECIST criteria
* ECOG Performance Status of 0, 1, or 2
* Life expectancy \> 3 months
* Adequate bone marrow, Renal, Hepatic reserve:
* absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL
* platelet count ≥ 100,000 cells/μL
* hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 X ULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN
* Alkaline Phosphatase (ALP) ≤ 2.0 X ULN
* Serum creatinine \< 1.5mg/dL or calculated creatinine clearance \> 60mL/min
* Signed a written informed consent
Exclusion Criteria
* Symptomatic brain lesion
* Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases
* Prior anticancer therapy within 4 weeks before enroll
* Active pregnancy test and Pregnant or nursing women
* Participation in any investigational drug study within 28 days prior to study entry
18 Years
FEMALE
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Yong-Sang Song, phD, Dr
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Seoul Metropolitan, South Korea
Countries
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References
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Kim HS, Park SY, Park CY, Kim YT, Kim BJ, Song YJ, Kim BG, Kim YB, Cho CH, Kim JH, Song YS. A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer. Br J Cancer. 2021 Jan;124(2):375-382. doi: 10.1038/s41416-020-01098-8. Epub 2020 Sep 30.
Other Identifiers
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11AOC09J
Identifier Type: -
Identifier Source: org_study_id
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