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

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00971191
• Other study ID #: A7471031
• Status: Terminated
• Phase: Phase 1
• First received: September 2, 2009
• Last updated: June 21, 2012
• Start date: February 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• PF-00299804
Brief exposure (5- 11 days) to study drug prior to surgical resection

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose		30 months	No
Secondary	To correlate molecular changes with specific gene and protein changes (eg, mutations, amplifications, over expression) in members of the EGFR and HER2 signal transduction pathways (eg, KRAS, EGFR, HER2)		30 months	No
Secondary	To assess the effect of short term treatment of PF-00299804 on serum levels of the extracellular domain of EGFR and other serum markers of HER signaling (eg, serum HER2/neu and serum E-cadherin)		30 months	No
Secondary	To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer		30 months	No
Secondary	To assess the safety and tolerability of PF-00299804 in this setting		30 months	Yes

External Links

•   To obtain contact information for a study center near you, click here.