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BAY 43-9006 (Sorafenib) to Treat Patients With Kaposi's Sarcoma

NCT00287495 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-12-12

No results posted yet for this study

Summary

Background:

* Kaposi's sarcoma (KS) is a disease in which cancer cells are found in the tissues under the skin or mucous membranes that line the mouth, nose, and anus. KS causes red or purple patches (lesions) on the skin or mucous membranes and spreads to other organs in the body, such as the lungs, liver, or intestinal tract.
* BAY 43-9006 inhibits the activity of several proteins or protein receptors in cells that are thought to be important to the progression of KS. Blocking these mechanisms may cause KS to get better.

Objectives:

* To learn about the toxicity and blood levels of BAY 43-9006 in people with KS who are and are not taking the anti-retroviral drug ritonavir.
* To look for evidence of a beneficial treatment effect of BAY 43-9006

Eligibility:

* Adults with confirmed KS, both HIV-positive and HIV-negative.
* Patients must have either 1) at least five measurable KS lesions with no previous local therapy, or 2) other measurable non-skin disease that permits evaluation of a response to treatment.

Design:

* Patients are randomly assigned to a specific dose of BAY 43-9006. They take the drug by mouth either once or twice daily, depending on their dose group, for up to 54 weeks.
* Drug blood levels are determined after patients have been taking BAY 43-9006 for 1 to 2 weeks by blood collections immediately before the dose and at 1, 2, 4, 8, 12, 16 and 24 hours after the dose.
* Patients are evaluated every 3 weeks with review of a medication diary, interview about drug side effects, physical examination, and assessment of KS lesions.
* KS lesions are photographed on entering the study and at other time points during the study.
* CD4 cell counts and HIV viral load are tested every 12 weeks.
* Biopsies are done at the start of the study, on day 15, and if it appears that all of the lesions have resolved.
* Other procedures, such as CT or MRI scans, may be done if medically indicated.

Conditions

  • Kaposi's Sarcoma
  • HHV-8
  • KSHV

Interventions

DRUG

BAY 43-9006

BAY 43-9006 200 mg once daily with dose escalation up to 400 mg twice daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Robert Yarchoan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-02
Primary Completion
2012-09-21
Completion
2017-10-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287495 on ClinicalTrials.gov