NCT00005931

Brief Summary

The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2000

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2000

First QC Date

June 30, 2000

Last Update Submit

June 23, 2005

Conditions

Sarcoma, KaposiHIV Infections

Keywords

Skin NeoplasmsSarcoma, KaposiAcquired Immunodeficiency SyndromeAntineoplastic AgentsEnzyme InhibitorsSU 5416Protein-Tyrosine Kinase

Interventions

SU5416DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are at least 18 years old.
  • Have KS.
  • Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten better or could not tolerate treatment therapy.
  • Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related edema (swelling) without sores, or KS-related edema of the arms and legs.
  • Agree to use an effective method of birth control during the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Are pregnant or breast-feeding.
  • Are allergic to Cremophor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alison L. Hannah

South San Francisco, California, 94080, United States

Location

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsSkin NeoplasmsAcquired Immunodeficiency Syndrome

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2000

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2000-12

Locations

US(1)