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NCT00001341 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00001341: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001341 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001341, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that directly inhibits TS. This phase I trial and pharmacokinetic study will describe and define the toxicities, determine the MTD, and describe the plasma pharmacokinetics of ZD1694 in pediatric patients with refractory cancer. The starting dose for this trial will be 2.0 mg/m(2) administered as a 15 minute IV infusion every 21 days.
Interventions
- DRUG ZD1694 (TOMUDEX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 1993-09 |
| Est. Completion | 2001-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001341
The ClinicalTrials.gov registry entry for NCT00001341 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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 ZD1694 (TOMUDEX) is the first listed.
NCT00001341 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001341 about?
NCT00001341 is a clinical study titled "A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease". Thymidylate synthase (TS), an enzyme which acts by utilizing 5,10-CH(2)FH(4) in the reductive methylation of deoxyuridylate (dUMP), is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target. ZD1694 is a new quinazolone folate analog that directly inhibits TS. Th...
What is the current status of trial NCT00001341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 1993-09. Estimated completion is 2001-06.
What interventions are being tested in trial NCT00001341?
The interventions under investigation include: ZD1694 (TOMUDEX) (DRUG).
Who is sponsoring clinical trial NCT00001341?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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