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A Phase 2, Open Label, Two Arm Trial To Evaluate The Efficacy Of PF-00299804 In Patients With Advanced NSCLC After Failure Of At Least One Prior Chemotherapy And Erlotinib


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non Small Cell Lung

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Trial Information

A Phase 2, Open Label, Two Arm Trial To Evaluate The Efficacy Of PF-00299804 In Patients With Advanced NSCLC After Failure Of At Least One Prior Chemotherapy And Erlotinib


Inclusion Criteria:



- Advanced Non-Small Cell Lung Cancer (NSCLC)

- Prior treatment with and failure of at least one regimen of chemotherapy and
erlotinib.

- Prior treatment with no more than two chemotherapy regimens, including adjuvant or
combined modality treatment.

- Measurable disease .

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- Tissue available for KRAS/ EGFR testing

- Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN

Exclusion Criteria:

- Chemotherapy

- Radiotherapy

- Biological or investigational agents within 4 weeks of baseline disease assessment.

- Patients who lack of tolerance of erlotinib therapy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall response, according to Response Evaluation Criteria in Solid Tumors in Non-Small Cell Lung Cancer (NSCLC), adenocarcinoma histology.

Outcome Time Frame:

6 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:

A7471002

NCT ID:

NCT00548093

Start Date:

April 2008

Completion Date:

May 2012

Related Keywords:

  • Carcinoma, Non Small Cell Lung
  • non-small cell lung cancer
  • advanced
  • previously treated
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site North Adams, Massachusetts  01247