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NCT00588445 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target

NCT00588445: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT00588445 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00588445, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target

Study Summary

The purpose of this research study is to: * see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery * see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene * see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene * see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment. * see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

Primary Outcome

Radiographic response is defined as a minor response ( \> 25% decrease in the sum of the products of measured lesions)

Interventions

  • DRUG Gefitinib

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2004-06
Est. Completion 2010-09
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT00588445 record still lists

NCT00588445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).

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

NCT00588445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00588445 about?

NCT00588445 is a clinical study titled "Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene". The purpose of this research study is to: * see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery * see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene * see if patients whose tumor does shrink with gefitinib treatment are mor...

What is the current status of trial NCT00588445?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2004-06. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00588445?

The interventions under investigation include: Gefitinib (DRUG).

Who is sponsoring clinical trial NCT00588445?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00588445's enrollment target sits among peer trials

65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00588445, the US trial registry maintained by the National Library of Medicine. NCT00588445 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.