Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist → Add completion date to calendar (.ics) →

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

FieldValue
Enrollment Target 60 participants
Start Date 1993-09
Est. Completion 2001-06
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001341 record still lists

NCT00001341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which ZD1694 (TOMUDEX) is the first listed.

NCT00001341 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001341's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00576069 · 60 participants

    Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

  • NCT01297400 · 60 participants · Phase 2

    Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

  • NCT01734122 · 60 participants

    Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

  • NCT01804634 · 60 participants · Phase 2

    Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00001341, the US trial registry maintained by the National Library of Medicine. NCT00001341 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.