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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00548093
First received: October 19, 2007
Last updated: June 4, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) and OS at 1 year (OS12m). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetics of the study drug [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Progression -free survival (PFS) and PFS at 6 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Explore patient reported outcomes of health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Exploratory molecular profiling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Best response by Response Evaluation Criterion in Solid Tumors (RECIST) in non-adenocarcinoma arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of overall response. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 30322
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
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:
No publications provided by Pfizer

Additional 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
Study First Received: October 19, 2007
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014