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| Sponsor: | SUGEN |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005931 |
Purpose
The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: SU5416 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| Official Title: | A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma |
| Estimated Enrollment: | 30 |
Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
More Information
| Study ID Numbers: | 310B, SU5416.027 |
| Study First Received: | June 30, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005931 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Skin Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents |
Enzyme Inhibitors SU 5416 Protein-Tyrosine Kinase |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Infection Protein Kinase Inhibitors Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Growth Inhibitors Angiogenesis Modulating Agents Retroviridae Infections RNA Virus Infections Neoplasms by Histologic Type |
Immune System Diseases Growth Substances Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes SU 5416 Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections |