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NCT00132158 · ClinicalTrials.gov registry record · Phase 1
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00132158 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants.
The verdict
NCT00132158, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.
Interventions
- DRUG Irinotecan (Camptosar), Gefitinib (Iressa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2005-09 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00132158
The ClinicalTrials.gov registry entry for NCT00132158 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Irinotecan (Camptosar), Gefitinib (Iressa) is the first listed.
NCT00132158 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00132158 about?
NCT00132158 is a clinical study titled "ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors". The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinot...
What is the current status of trial NCT00132158?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2005-09. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00132158?
The interventions under investigation include: Irinotecan (Camptosar), Gefitinib (Iressa) (DRUG).
Who is sponsoring clinical trial NCT00132158?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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