Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
NCT01630018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2016-09-22
Summary
The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).
Conditions
- Epithelial Ovarian Cancer
Interventions
- DRUG
-
Topotecan
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
- DRUG
-
Belotecan
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Yong-Sang Song, phD, Dr · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2014-06-30
- Completion
- 2014-06-30
Countries
- South Korea
Study Locations
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