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NCT00447226 · ClinicalTrials.gov registry record · Phase 2

Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

A Phase 2 study, sponsored by GlaxoSmithKline.

Terminated
Registry status
Phase 2
Development phase
32
Enrollment target

NCT00447226: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.

NCT00447226 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00447226, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.

TERMINATED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study Summary

This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.

Primary Outcome

Per Response Evaluation Criteria In Solid Tumors (RECIST): Complete response (CR), disappearance of all lesions; partial response (PR), \>=30% decrease in the measurements of the largest lesions; stable disease (SD), insufficient shrinkage to qualify for PR or insufficient increase to qualify for progressive disease (PD); PD, \>=20% increase in measurements of lesions or appearance of new lesions. Data were not fully analyzed due to early study termination.

Interventions

  • DRUG Oral lapatinib tablets or placebo tablets

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2007-05
Est. Completion 2009-09
Phase Phase 2
GlaxoSmithKline

1,345 total trials

Why NCT00447226 stopped before completion

NCT00447226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 1 intervention - of which Oral lapatinib tablets or placebo tablets is the first listed.

NCT00447226 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00447226 about?

NCT00447226 is a clinical study titled "Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists". This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.

What is the current status of trial NCT00447226?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2007-05. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00447226?

The interventions under investigation include: Oral lapatinib tablets or placebo tablets (DRUG).

Who is sponsoring clinical trial NCT00447226?

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 NCT00447226's enrollment target sits among peer trials

32 1563rd of 2000 higher than 423 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 NCT00447226, the US trial registry maintained by the National Library of Medicine. NCT00447226 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.