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NCT00863122 · ClinicalTrials.gov registry record · Early Phase 1
Concentration and Activity of Lapatinib in Vestibular Schwannomas
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
NCT00863122 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 26 participants.
The verdict
NCT00863122, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Tumors can grow on the auditory nerves and can cause hearing loss. A common type of tumor that does this is a vestibular schwannoma (VS), or acoustic neuroma. These tumors are not cancerous. Most often, people have only one VS. Occasionally, people have more than one VS and may have a condition called neurofibromatosis type 2 (NF2). Because VS can cause hearing loss, many people with VS will have treatment to preserve their hearing. This treatment usually involves surgery or radiation therapy. There are risks to these procedures, and sometimes they do not work to prevent hearing loss. Because surgery and radiation have risks and are not able to help everyone with VS, other methods of treatment are being explored. One area of exploration is looking to see if there is a drug that can be taken that might prevent the VS from growing larger and causing hearing loss, and might possibly even cause the VS to shrink in size. This study is exploring whether a drug that is approved by the FDA and is currently used to treat breast cancer might also work to treat VS. This study will measure the amount of drug that travels from the bloodstream and arrives at the tumor. This drug is safe and has few side effects. If this drug is shown to reach the tumor, it might be used in the future to treat VS without needing surgery or radiation. This study is recruiting people who are having surgery for VS. If you are going to have surgery to treat a VS, you may be eligible to participate.
Interventions
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-08 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00863122
The ClinicalTrials.gov registry entry for NCT00863122 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lapatinib is the first listed.
NCT00863122 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00863122 about?
NCT00863122 is a clinical study titled "Concentration and Activity of Lapatinib in Vestibular Schwannomas". Tumors can grow on the auditory nerves and can cause hearing loss. A common type of tumor that does this is a vestibular schwannoma (VS), or acoustic neuroma. These tumors are not cancerous. Most often, people have only one VS. Occasionally, people have more than one VS and may have a condition call...
What is the current status of trial NCT00863122?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2009-06. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00863122?
The interventions under investigation include: lapatinib (DRUG).
Who is sponsoring clinical trial NCT00863122?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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