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NCT00818441 · ClinicalTrials.gov registry record · Phase 2

Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
119
Enrollment target

NCT00818441: Completed Phase 2 study, sponsored by Pfizer.

NCT00818441 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 119 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00818441, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
119 participants
Enrollment target

Study Summary

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (\<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.

Primary Outcome

PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (\>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference

Interventions

  • DRUG Dacomitinib (PF-00299804)

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2009-03-11
Est. Completion 2015-04-30
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT00818441 record still lists

NCT00818441 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).

The record links to 0 conditions, and to 1 intervention - of which Dacomitinib (PF-00299804) is the first listed.

NCT00818441 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00818441 about?

NCT00818441 is a clinical study titled "Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung". This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (\<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGF...

What is the current status of trial NCT00818441?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2009-03-11. Estimated completion is 2015-04-30.

What interventions are being tested in trial NCT00818441?

The interventions under investigation include: Dacomitinib (PF-00299804) (DRUG).

Who is sponsoring clinical trial NCT00818441?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00818441's enrollment target sits among peer trials

119 618th of 2000 higher than 1,383 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 NCT00818441, the US trial registry maintained by the National Library of Medicine. NCT00818441 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.