Trials / Completed
CompletedNCT00082134
Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ILX651 |
Timeline
- Completion
- 2005-12-01
- First posted
- 2004-05-04
- Last updated
- 2015-03-05
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00082134. Inclusion in this directory is not an endorsement.