A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00769067

Purpose

This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Erlotinib Drug: PF-00299804	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 2 Trial Of PF-00299804 Versus Erlotinib For The Treatment Of Advanced Non Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression- Free Survival for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall safety profile for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
Patient Reported Outcomes (PRO) of health related quality of life and disease/treatment related symptoms for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
KRAS and HER family mutations in circulating tumor DNA in blood and in tissue (from original diagnostic or recently obtained sample) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Best Overall Response per RECIST (BOR) for patients in each arm [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Duration of Response for patients in each arm [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Overall Survival for patients in each arm [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Pre and post treatment levels of circulating shed receptors of the HER signaling pathways or protein/receptors which interact with or are part of HER signaling pathway [ Time Frame: 13 months ] [ Designated as safety issue: No ]
EGFR mutations, including T790M, in blood at baseline and at end of study [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Trough concentrations of PF 00299804 after repeated dosing; [ Time Frame: 13months ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Erlotinib erlotinib by continuous oral dosing at 150 mg daily
B: Experimental	Drug: PF-00299804 PF-00299804 by continuous oral dosing at 45mg daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

advanced measurable Non-Small Cell Lung Cancer (NSCLC);
progressed after 1-2 prior chemotherapy;
Eastern Cooperative Oncology Group (ECOG) 0-2;
tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
active or untreated Central Nervous System (CNS) metastases;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769067

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Connecticut
Pfizer Investigational Site	Recruiting
Norwalk, Connecticut, United States, 06856
Pfizer Investigational Site	Recruiting
Bridgeport, Connecticut, United States, 06610
Pfizer Investigational Site	Recruiting
Fairfield, Connecticut, United States, 06824
Pfizer Investigational Site	Recruiting
Hartford, Connecticut, United States, 06102
Pfizer Investigational Site	Recruiting
Avon, Connecticut, United States, 06001
Pfizer Investigational Site	Recruiting
Trumbull, Connecticut, United States, 06611
Pfizer Investigational Site	Recruiting
Hartford, Connecticut, United States, 06106
Pfizer Investigational Site	Recruiting
Hartford, Connecticut, United States, 16106
Pfizer Investigational Site	Recruiting
Wethersfield, Connecticut, United States, 06109
Pfizer Investigational Site	Recruiting
Willimantic, Connecticut, United States, 06226
Pfizer Investigational Site	Recruiting
Waterbury, Connecticut, United States, 06708
United States, Georgia
Pfizer Investigational Site	Not yet recruiting
Macon, Georgia, United States, 31201
Pfizer Investigational Site	Not yet recruiting
Warner Robins, Georgia, United States, 31093
Pfizer Investigational Site	Not yet recruiting
Augusta, Georgia, United States, 30901
Pfizer Investigational Site	Not yet recruiting
Augusta, Georgia, United States, 30909
United States, Maryland
Pfizer Investigational Site	Not yet recruiting
Kensington, Maryland, United States, 20895
Pfizer Investigational Site	Not yet recruiting
Rockville, Maryland, United States, 20850
United States, Mississippi
Pfizer Investigational Site	Not yet recruiting
Corinth, Mississippi, United States, 38834
Pfizer Investigational Site	Not yet recruiting
Southaven, Mississippi, United States, 38671
United States, Montana
Pfizer Investigational Site	Not yet recruiting
Billings, Montana, United States, 59101
Pfizer Investigational Site	Not yet recruiting
Butte, Montana, United States, 59701
United States, Tennessee
Pfizer Investigational Site	Not yet recruiting
Memphis, Tennessee, United States, 38120
United States, Wyoming
Pfizer Investigational Site	Not yet recruiting
Cody, Wyoming, United States, 82414
Australia, Victoria
Pfizer Investigational Site	Not yet recruiting
Wodonga, Victoria, Australia, 3690

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7471028
Study First Received:	October 7, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00769067
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Lung cancer, advanced, second or third line

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009