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Dacomitinib (PF-00299804) As ...

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

Last Updated: 2019-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-11

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Non-small Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A

Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC

Group Type EXPERIMENTAL

Dacomitinib (PF-00299804)

Intervention Type DRUG

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).

Cohort B

Dacomitinib in patients with HER2 mutated or amplified NSCLC

Group Type EXPERIMENTAL

Dacomitinib (PF-00299804)

Intervention Type DRUG

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.

Interventions

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Dacomitinib (PF-00299804)

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced adenocarcinoma of lung, measurable disease
* Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
* patients with known EGFR activating mutation regardless of smoking status
* ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion Criteria

* Active brain metastases
* Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
* known EGFR wild type NSCLC

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of California, Irvine

Orange, California, United States

Site Status

Chao Family Comprehensive Cancer Center UC Irvine Medical Center

Orange, California, United States

Site Status

Bay Area Cancer Research Group, LLC

Pleasant Hill, California, United States

Site Status

Pacific Cancer Care

Salinas, California, United States

Site Status

San Francisco General Hospital

San Francisco, California, United States

Site Status

University of Colorado Clinical Trials Office (CTO)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status