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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NCT00971191

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer (NSCLC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Non-Small Cell Lung Cancer (NSCLC)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
NCT00971191
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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Non-Small Cell Lung Cancer (NSCLC)
Intervention  ICMJE Drug: PF-00299804
Brief exposure (5- 11 days) to study drug prior to surgical resection
Study Arms  ICMJE Experimental: treatment
Patients treated with brief exposure to PF-00299804 prior to surgical resection
Intervention: Drug: PF-00299804
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 21, 2012)		22
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2009)		75
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00971191
Other Study ID Numbers  ICMJE A7471031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP