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NCT00001269 · ClinicalTrials.gov registry record · Phase 1

Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
100
Enrollment target

NCT00001269: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00001269 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001269, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target

Study Summary

This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.

Interventions

  • DRUG IL-3

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 1991-05
Est. Completion 2001-02
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001269 record still lists

NCT00001269 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).

The record links to 0 conditions, and to 1 intervention - of which IL-3 is the first listed.

NCT00001269 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001269 about?

NCT00001269 is a clinical study titled "Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer". This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.

What is the current status of trial NCT00001269?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 1991-05. Estimated completion is 2001-02.

What interventions are being tested in trial NCT00001269?

The interventions under investigation include: IL-3 (DRUG).

Who is sponsoring clinical trial NCT00001269?

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 NCT00001269's enrollment target sits among peer trials

100 546th of 2000 higher than 1,411 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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Source: ClinicalTrials.gov NCT00001269, the US trial registry maintained by the National Library of Medicine. NCT00001269 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.