A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-05-31

Brief Summary

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This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug.

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Detailed Description

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The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in February 2010. Based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. The discontinuation of the study is not due to any safety issue.

Conditions

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Non-Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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treatment

Patients treated with brief exposure to PF-00299804 prior to surgical resection

Group Type EXPERIMENTAL

PF-00299804

Intervention Type DRUG

Brief exposure (5- 11 days) to study drug prior to surgical resection

Interventions

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PF-00299804

Brief exposure (5- 11 days) to study drug prior to surgical resection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
* Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.

Exclusion Criteria

* Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.
* Prior or concurrent radiation therapy to tumor at site of planned resection.
* Congestive heart failure (LVEF \< 50%), uncontrolled hypertension, significant ventricular arrythmia.
* Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.
* Prior or concurrent radiation therapy to tumor at site of planned resection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No