A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Sponsor
Anderson Clinical Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00002439
Collaborator
Ligand Pharmaceuticals (Industry)
Study Details
Study Description
Brief Summary
The purpose of this study is to see if ALRT1057 gel is safe and effective in treating Kaposi's sarcoma (KS) when applied to skin .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
This is a Phase 3 double-blind study. KS patients are randomized to 1 of 2 treatment arms. They receive either ALRT1057 gel or placebo for 12 weeks. If progressive disease for KS is noted before Week 12, patients are switched to the other blinded treatment arm. If a response or disease progression that has not persisted for at least 4 weeks as of Week 12 occurs, treatment on the blinded arm is continued for up to 4 additional weeks, or until response of disease progression is confirmed. After that time or after 12 weeks of treatment, open-label ALRT1057 may be received.
Study Design
Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Information not available
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Anderson Clinical Research
- Ligand Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00002439
Other Study ID Numbers:
- 272A
- L1057T-31
- 96ACR-LIG1
First Posted:
Aug 31, 2001
Last Update Posted:
Jun 24, 2005
Last Verified:
Aug 1, 1997