A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002188 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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Tracking Information | |||
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First Submitted Date ICMJE | November 2, 1999 | ||
First Posted Date ICMJE | August 31, 2001 | ||
Last Update Posted Date | June 24, 2005 | ||
Study Start Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma | ||
Official Title ICMJE | Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma. | ||
Brief Summary | The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS). | ||
Detailed Description | Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active. Thirteen patients are treated initially. If at least one response is observed in these patients, up to 14 additional patients will be evaluated. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE |
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Intervention ICMJE | Drug: Alitretinoin | ||
Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE |
27 | ||
Original Enrollment ICMJE | Same as current | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. Prior Medication: Excluded:
Required: Approved antiretroviral therapy. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002188 | ||
Other Study ID Numbers ICMJE | 271A L1057-28 96ACR-LIG2 |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Anderson Clinical Research | ||
Collaborators ICMJE | Ligand Pharmaceuticals | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | August 1997 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |