PF-00299804 As a Single Oral Agent In Untreated Adenocarcinoma Of The Lung In Never Or Former Light Smokers - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00818441

Purpose

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years)

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Open Label, Trial Of PF-00299804 In Untreated Advanced Adenocarcinoma Of The Lung In Never Or Former Light Smokers

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression-Free survival at 4 months (PFS4m) [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best Overall Response (BOR) per RECIST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Duration of Response (DR) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Progression-free Survival (PFS) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Overall safety profile as characterized by type, frequency, severity as graded by NCI Common Toxicity Criteria for Adverse Events version 3.0 (NCI CTCAEv3.0), timing and relationship to treatment, and laboratory abnormalities observed; [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and its Lung Cancer module [ Time Frame: 10 months ] [ Designated as safety issue: No ]
(LC13); [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Trough concentrations of PF-00299804 in blood after repeated dosing; and concentrations of PF 00299804 in biofluid (ie, [ Time Frame: 10months ] [ Designated as safety issue: No ]
Exploratory endpoints: EGFR and HER signalling pathways in blood and tissue at baseline and on study [ Time Frame: 12 monhts ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-00299804: Experimental not specified	Drug: PF-00299804 PF-00299804 at 45 mg daily by continuous oral dosing

Eligibility

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

Criteria

Inclusion Criteria:

Advanced adenocarcinoma of lung, measurable disease
Non-smoker, or former light (less than 10 pack years and stopped at least 15 years)
ECOG(Eastern Cooperative Oncology Group) 0-1

Exclusion Criteria:

Active brain metastases
Prior systemic therapy for advanced disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818441

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, South Carolina
Pfizer Investigational Site
Easley, South Carolina, United States, 29640
Pfizer Investigational Site
Greenville, South Carolina, United States, 29605
Pfizer Investigational Site
Greenville, South Carolina, United States, 29615
Pfizer Investigational Site
Spartanburg, South Carolina, United States, 29307
Pfizer Investigational Site
Seneca, South Carolina, United States, 29672
Pfizer Investigational Site
Greet, South Carolina, United States, 29650

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:	A7471017
Study First Received:	January 5, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00818441
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

lung cancer adenocarcinoma untreated nonsmoker former smoker

Study placed in the following topic categories:

Adenocarcinoma of lung
Lung Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009