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NCT00727233 · ClinicalTrials.gov registry record · Phase 1
Sorafenib to Treat Children and Young Adults With Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00727233: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00727233 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00727233, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: Patients with neurofibromatosis type 1 are at increased risk of developing tumors called plexiform neurofibromas (PN) that arise from nerves. These tumors are usually non-cancerous, but they can cause serious medical problems. Sorafenib was recently approved to treat patients with kidney cancer and is now being tested in children with cancer. It affects several pathways thought to be important for the development and growth of PN and may therefore shrink these tumors or slow their growth. Objectives: To determine the highest dose of sorafenib that can safely be given to children and young adults with PN. To identify the side effects of sorafenib in these patients. To study how the body handles sorafenib by measuring the amount of drug in the bloodstream over time To determine how the drug affects blood flow and blood cells and proteins. To determine if sorafenib can shrink or slow the growth of PN. To determine the effects of sorafenib on learning, attention, memory, and quality of life. Eligibility: Patients between 3 and 18 years of age with NF1 who have inoperable PN that can cause significant disability. Design: Patients take sorafenib tablets twice a day in 28-day treatment cycles. They may continue treatment until their tumor grows or they develop unacceptable drug side effects. In this dose escalation study, the dosage is increased with every 3 to 6 children who are enrolled until the highest safe dose is determined. In any case, the dose will not exceed that used in children with cancer. Patients are monitored regularly with physical examinations, blood and urine tests, MRI scans and quality-of-life questionnaires. Patients whose bones are still growing have periodic x-rays of the hips and lower legs to monitor for possible changes in the structure of growing bones. Patients have periodic tests of learning and memory before starting treatment and before cycles 4, 12, 18 and 24. Patients have pharmacokinetic studies to examine how
Interventions
- DRUG Nexavar (BAY 43-9006) (Sorafenib)
- DRUG Toxicity, Pharmacokinetics
- DRUG Pharmacodynamics
- DRUG Radiographic Evaluation
- DRUG QOL assessment, Neuropsychological
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2008-07-08 |
| Est. Completion | 2011-06-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00727233
The ClinicalTrials.gov registry entry for NCT00727233 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 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 5 interventions - of which Nexavar (BAY 43-9006) (Sorafenib) is the first listed.
NCT00727233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00727233 about?
NCT00727233 is a clinical study titled "Sorafenib to Treat Children and Young Adults With Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas". Background: Patients with neurofibromatosis type 1 are at increased risk of developing tumors called plexiform neurofibromas (PN) that arise from nerves. These tumors are usually non-cancerous, but they can cause serious medical problems. Sorafenib was recently approved to treat patients with kidn...
What is the current status of trial NCT00727233?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2008-07-08. Estimated completion is 2011-06-16.
What interventions are being tested in trial NCT00727233?
The interventions under investigation include: Nexavar (BAY 43-9006) (Sorafenib) (DRUG), Toxicity, Pharmacokinetics (DRUG), Pharmacodynamics (DRUG), Radiographic Evaluation (DRUG), QOL assessment, Neuropsychological (DRUG).
Who is sponsoring clinical trial NCT00727233?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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