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NCT00287495 · ClinicalTrials.gov registry record · Phase 1
BAY 43-9006 (Sorafenib) to Treat Patients With Kaposi's Sarcoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00287495: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00287495 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00287495, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
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.
Interventions
- DRUG BAY 43-9006
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-02-02 |
| Est. Completion | 2017-10-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00287495
The ClinicalTrials.gov registry entry for NCT00287495 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BAY 43-9006 is the first listed.
NCT00287495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00287495 about?
NCT00287495 is a clinical study titled "BAY 43-9006 (Sorafenib) to Treat Patients With Kaposi's Sarcoma". 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 lung...
What is the current status of trial NCT00287495?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2006-02-02. Estimated completion is 2017-10-18.
What interventions are being tested in trial NCT00287495?
The interventions under investigation include: BAY 43-9006 (DRUG).
Who is sponsoring clinical trial NCT00287495?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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