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NCT00514046 · ClinicalTrials.gov registry record · Phase 1
Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00514046: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00514046 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00514046, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Background: * Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called multiple endocrine neoplasia (MEN). * Vandetanib is an experimental drug that blocks a defective protein receptor (rearranged during transfection (RET) receptor) found on the surface of cancer cells in people with MEN. It is thought that this protein is a primary cause of MTC in people with MEN. Objectives: * To study the activity of Vandetanib in children and adolescents with MEN-related MTC by measuring the change in tumor size, in blood levels of proteins produced the tumor (calcitonin and carcinoembryonic antigen (CEA) and in tumor-related diarrhea. * To determine the safety and tolerability of Vandetanib in children and adolescents. * To study how the body handles Vandetanib in children and adolescents. * To determine the effect of Vandetanib on the survival of children and adolescents with MTC. Eligibility: -Children and adolescents 5 to 18 years of age with MTC whose tumor cannot be surgically removed or has grown back after treatment or has metastasized (spread beyond the thyroid gland). Design: * Patients take Vandetanib once a day in 28-day cycles. The first patients enrolled in the study are started on a low dose of Vandetanib to determine tolerability. * Patients have periodic blood tests, electrocardiograms, and blood pressure measurements to look for side effects of Vandetanib. * Blood tests and imaging scans (magnetic resonance imaging (MRI), computed tomography (CT), bone and octreoscan) are done every 8 weeks for the first 32 weeks of treatment and then every 16 weeks for the duration of the treatment period. * Patients who have tumor-related diarrhea keep a daily record of the number and consistency of bowel movements.
Interventions
- DRUG Vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-07-20 |
| Est. Completion | 2020-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00514046
The ClinicalTrials.gov registry entry for NCT00514046 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 Vandetanib is the first listed.
NCT00514046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00514046 about?
NCT00514046 is a clinical study titled "Vandetanib to Treat Children and Adolescents With Medullary Thyroid Cancer". Background: * Medullary thyroid carcinoma (MTC) is common in people with a genetic disorder called multiple endocrine neoplasia (MEN). * Vandetanib is an experimental drug that blocks a defective protein receptor (rearranged during transfection (RET) receptor) found on the surface of cancer cells i...
What is the current status of trial NCT00514046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-07-20. Estimated completion is 2020-11-01.
What interventions are being tested in trial NCT00514046?
The interventions under investigation include: Vandetanib (DRUG).
Who is sponsoring clinical trial NCT00514046?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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