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NCT00098254 · ClinicalTrials.gov registry record · Phase 2
BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT00098254: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00098254 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098254, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas. Patients 18 years of age and older with NSCLC that has recurred or progressed after one regimen of chemotherapy may be eligible for this study. Candidates are screened with a medical history and physical examination; blood tests; tumor biopsy (see below); chest x-ray; electrocardiogram; and imaging studies, including positron emission tomography-computed tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below). Participants take BAY 43-9006 by mouth twice a day, morning and evening. On the first and 15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies; that is, a test of how the body handles the drug. For the test, blood is collected at intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to determine the drug's level in the bloodstream. Treatment with BAY 43-9006 continues until the study doctor determines that the medication is not beneficial or the patient wishes to withdraw from the study. In addition to drug therapy, patients undergo the following tests and procedures: * Physical examination every 4 weeks * Blood pressure checks once a week during the first 4 weeks * Blood tests every week * CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate the tumor's response to treatment. CT is an x-ray test that provides detailed pictures of the inside of the body. It can be done from different angles, providing a 3-dimensional picture of the part of the body being studied and allowing the doctor to see the location, nature, and extent of disease. MRI uses a powerful magnet and radio waves instead of x-rays to produce accurate, detailed pictures of organs and tissues. * PET-CT approximately every 8
Interventions
- DRUG BAY 43-9006 (Sorafenib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2004-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00098254
The ClinicalTrials.gov registry entry for NCT00098254 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 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 (Sorafenib) is the first listed.
NCT00098254 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00098254 about?
NCT00098254 is a clinical study titled "BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer". This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas. Patients 18 years of age and older with NSCLC that has recur...
What is the current status of trial NCT00098254?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2004-12. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00098254?
The interventions under investigation include: BAY 43-9006 (Sorafenib) (DRUG).
Who is sponsoring clinical trial NCT00098254?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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