Trials / Completed
CompletedNCT01497873
A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
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 Relapsed Small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Chong Kun Dang Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
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 Relapsed Small Cell Lung Cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Topotecan | 1.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more |
| DRUG | Belotecan | 0.5 mg/m\^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2017-12-01
- Completion
- 2018-03-01
- First posted
- 2011-12-23
- Last updated
- 2018-12-27
Locations
14 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01497873. Inclusion in this directory is not an endorsement.