Trials / Completed
CompletedNCT00319969
Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.
A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients With Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Celgene Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the objective tumor response rate of amrubicin or standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who have chemotherapy sensitive recurrent or progressive.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Amrubicin | Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
| DRUG | Topotecan | Topotecan 1.5mg/m\<2\> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-07-01
- Completion
- 2009-01-01
- First posted
- 2006-04-27
- Last updated
- 2009-09-30
Locations
47 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00319969. Inclusion in this directory is not an endorsement.