Trials / Completed
CompletedNCT00061854
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time and 12-month survival rate of patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1. Patients are followed for survival every 3 months after discontinuing study treatment. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | soblidotin |
Timeline
- Start date
- 2003-04-01
- Primary completion
- 2005-05-01
- Completion
- 2005-05-01
- First posted
- 2003-06-06
- Last updated
- 2012-05-16
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00061854. Inclusion in this directory is not an endorsement.