Trials / Completed
CompletedNCT01630018
Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Chong Kun Dang Pharmaceutical · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2012-06-28
- Last updated
- 2016-09-22
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01630018. Inclusion in this directory is not an endorsement.