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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase I Study of Sorafenib in Patients With Kaposi's Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	NCI	NCI-06-C-0083 7048, NCI-7048, NCI-P6700, NCT00304122

Special Category: NCI Web site featured trial, NIH Clinical Center trial

Trial Description

Purpose:

Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

This phase I trial is studying the side effects and best dose of sorafenib in treating patients with Kaposi’s sarcoma (KS).

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• HIV -related or HIV-unrelated KS
• Patients with HIV-related KS must be on highly active antiretroviral therapy
• Measurable disease
• At least 3 weeks since chemotherapy or other treatment for KS except antiretroviral therapy
• No previous sorafenib
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive sorafenib by mouth once or twice a day for up to approximately 1 year.

After finishing treatment, patients will be evaluated at 3-6 weeks.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Robert Yarchoan, MD, Protocol chair		Ph: 301-496-8959

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Featured trial article
Web site for additional information

Registry Information
Official Title		Phase I and Pharmacokinetic Study of BAY 43-9006 (Sorafenib) in Patients with Kaposi's Sarcoma
Trial Start Date		2006-07-03
Trial Completion Date		2008-05-08 (estimated)
Registered in ClinicalTrials.gov		NCT00304122
Date Submitted to PDQ		2006-01-30
Information Last Verified		2009-07-05

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