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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

30 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A7471031

NCT ID:

NCT00971191

Start Date:

February 2010

Completion Date:

May 2012

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • Stage I - III surgical resection molecular change brief pre-operative exposure
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740