Back to resultsA 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
Primary Purpose
Non-Small Cell Lung Cancer (NSCLC)
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-00299804
Sponsored by
About this trial
This is an interventional basic science trial for Non-Small Cell Lung Cancer (NSCLC) focused on measuring Stage I - III surgical resection molecular change brief pre-operative exposure
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
Patients treated with brief exposure to PF-00299804 prior to surgical resection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer
To assess the safety and tolerability of PF-00299804 in this setting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00971191
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer (NSCLC)
Keywords
Stage I - III surgical resection molecular change brief pre-operative exposure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
Patients treated with brief exposure to PF-00299804 prior to surgical resection
Intervention Type
Drug
Intervention Name(s)
PF-00299804
Intervention Description
Brief exposure (5- 11 days) to study drug prior to surgical resection
Primary Outcome Measure Information:
Title
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
Time Frame
30 months
Secondary Outcome Measure Information:
Title
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)
Time Frame
30 months
Title
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)
Time Frame
30 months
Title
To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer
Time Frame
30 months
Title
To assess the safety and tolerability of PF-00299804 in this setting
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471031&StudyName=A%20Study%20In%20Patients%20Who%20Will%20Undergo%20Surgical%20Removal%20Of%20%20Non-Small%20Cell%20Lung%20Cancer%20To%20Evaluate%20Molecular%20Changes%20That%20Occur%20In%20T
Description
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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
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