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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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:	October 2010
Estimated Primary Completion Date:	October 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 CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 82 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7471028
Study First Received:	October 7, 2008
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00769067 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Lung cancer
advanced
second or third line

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010