PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-29

Study Completion Date

2012-06-11

Brief Summary

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To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.

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Detailed Description

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Conditions

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Carcinoma, Non Small Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

descriptive: adenocarcinoma histology

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

PF-00299804 orally at 45 mg daily, on continuous schedule

2

descriptive: non-adenocarcinoma histology

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

PF-00299804 orally at 45 mg daily, on continuous schedule

Interventions

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PF-00299804

PF-00299804 orally at 45 mg daily, on continuous schedule

Intervention Type DRUG

PF-00299804

PF-00299804 orally at 45 mg daily, on continuous schedule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced Non-Small Cell Lung Cancer (NSCLC)
* Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
* Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
* Measurable disease .
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Tissue available for KRAS/ EGFR testing
* Creatinine clearance \> 40 cc/min or serum creat \< 1.5 x ULN

Exclusion Criteria

* Chemotherapy
* Radiotherapy
* Biological or investigational agents within 4 weeks of baseline disease assessment.
* Patients who lack of tolerance of erlotinib therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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City of Hope

Duarte, California, United States

Site Status

City of Hope Medical Group

Pasadena, California, United States

Site Status

City of Hope South Pasadena Cancer Center

South Pasadena, California, United States

Site Status

Rocky Mountain Lions Eye Institute

Aurora, Colorado, United States

Site Status

University of Colorado Hospital, Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

University of Colorado Hospital, Anschutz Inpatient Pavilion

Aurora, Colorado, United States

Site Status