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

NCT00818441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-01-08

Study results available
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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.

Conditions

  • Carcinoma, Non-small Cell

Interventions

DRUG

Dacomitinib (PF-00299804)

Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).

DRUG

Dacomitinib (PF-00299804)

In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-11
Primary Completion
2012-04-27
Completion
2015-04-30

Countries

  • United States
  • Hong Kong
  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00818441 on ClinicalTrials.gov