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NCT00526669 · ClinicalTrials.gov registry record · Phase 2

Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT00526669: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT00526669 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00526669, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study Summary

The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.

Primary Outcome

Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the ta

Interventions

  • DRUG Lapatinib and Capecitabine

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2008-03
Est. Completion 2015-01
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT00526669 record still lists

NCT00526669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).

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

NCT00526669 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00526669 about?

NCT00526669 is a clinical study titled "Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib". The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.

What is the current status of trial NCT00526669?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2008-03. Estimated completion is 2015-01.

What interventions are being tested in trial NCT00526669?

The interventions under investigation include: Lapatinib and Capecitabine (DRUG).

Who is sponsoring clinical trial NCT00526669?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00526669's enrollment target sits among peer trials

68 967th of 2000 higher than 1,027 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 NCT00526669, the US trial registry maintained by the National Library of Medicine. NCT00526669 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.