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PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00548093
First Posted: October 23, 2007
Last Update Posted: June 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.

Condition Intervention Phase
Carcinoma, Non Small Cell Lung Drug: PF-00299804 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Best Overall response, according to Response Evaluation Criteria in Solid Tumors in Non-Small Cell Lung Cancer (NSCLC), adenocarcinoma histology. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Overall survival (OS) and OS at 1 year (OS12m). [ Time Frame: 18 months ]
  • To characterize the pharmacokinetics of the study drug<br> [ Time Frame: 6 months ]
  • Progression -free survival (PFS) and PFS at 6 months. [ Time Frame: 12 months ]
  • Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed. [ Time Frame: 6 months ]
  • Explore patient reported outcomes of health related quality of life [ Time Frame: 6 months ]
  • Exploratory molecular profiling [ Time Frame: 12 months ]
  • Best response by Response Evaluation Criterion in Solid Tumors (RECIST) in non-adenocarcinoma arm [ Time Frame: 6 months ]
  • Duration of overall response. [ Time Frame: 6 months ]

Enrollment: 66
Study Start Date: April 2008
Study Completion Date: May 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
descriptive: adenocarcinoma histology
Drug: PF-00299804
PF-00299804 orally at 45 mg daily, on continuous schedule
Experimental: 2
descriptive: non-adenocarcinoma histology
Drug: PF-00299804
PF-00299804 orally at 45 mg daily, on continuous schedule

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548093


Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States, 91010
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
South Pasadena, California, United States, 91030
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Farmington Hills, Michigan, United States, 48334
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00548093     History of Changes
Other Study ID Numbers: A7471002
First Submitted: October 19, 2007
First Posted: October 23, 2007
Last Update Posted: June 7, 2012
Last Verified: June 2012

Keywords provided by Pfizer:
non-small cell lung cancer
advanced
previously treated

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action