PF-00299804 As a Single Oral Agent In Untreated Adenocarcinoma Of The Lung In Non-Smokers Or Former Light Smokers - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 5, 2009

Last Updated Date

May 7, 2009

Start Date ^†

January 2009

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00818441 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

PF-00299804 As a Single Oral Agent In Untreated Adenocarcinoma Of The Lung In Non-Smokers Or Former Light Smokers

Official Title ^†

A Phase 2, Open Label, Trial Of PF-00299804 In Untreated Advanced Adenocarcinoma Of The Lung In Never Or Former Light Smokers

Brief Summary

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)

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Carcinoma, Non-Small Cell

Intervention ^†

Drug: PF-00299804

Study Arms / Comparison Groups

Experimental: not specified

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

March 2012

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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

Location Countries ^†

United States, Hong Kong

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00818441

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.