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 (Responsible Party):	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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	188
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2012
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: Erlotinib Continuous oral dosing at 150 mg daily.
Experimental: B	Drug: PF-00299804 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

Show 68 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
ClinicalTrials.gov Identifier:	NCT00769067 History of Changes
Other Study ID Numbers:	A7471028
Study First Received:	October 7, 2008
Last Updated:	May 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Lung cancer
advanced
second or third line

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012