Trials / Completed
CompletedNCT00078455
Study of ILX651 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, non-randomized, open label study of ILX651 in patients with locally advanced or metastatic non-small cell lung carcinoma (NSCLC). Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered intravenously (IV) daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate. The secondary objectives are to determine the progression free survival, duration of response, time to tumor progression, survival, safety/tolerability of ILX651, and to evaluate pharmacokinetic profile.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ILX651 |
Timeline
- Start date
- 2003-12-01
- Completion
- 2005-08-01
- First posted
- 2004-03-01
- Last updated
- 2015-03-05
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00078455. Inclusion in this directory is not an endorsement.