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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: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT00132158 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00132158 record still lists
NCT00132158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Irinotecan (Camptosar), Gefitinib (Iressa) is the first listed.
NCT00132158 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00132158's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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