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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: PF-00299804

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971191

A7471031

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

treatment

Experimental group

Description:

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

Treatment:

Drug: PF-00299804