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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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NCT00971191

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 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.

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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
May 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00971191
A7471031
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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