PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib. - Full Text View

Purpose

To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Erlotinib Erlotinib hydrochloride

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, Two Arm Trial To Evaluate The Efficacy Of PF-00299804 In Patients With Advanced NSCLC After Failure Of At Least One Prior Chemotherapy And Erlotinib.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Best Overall response, according to Response Evaluation Criteria in Solid Tumors in NSCLC, adenocarcinoma histology. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS) and OS at 1 year (OS12m). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To characterize the pharmacokinetics of the study drug [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Progression -free survival (PFS) and PFS at 6 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety profile as characterized by type, frequency, severity [as graded by NCI CTCAE v.3.0], timing and relationship to study treatment of adverse events and laboratory abnormalities observed. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Explore patient reported outcomes of health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Exploratory molecular profiling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Best response by RECIST in non-adenocarcinoma arm [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Duration of overall response. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	74
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental descriptive: adenocarcinoma histology	Drug: PF-00299804 PF-00299804 orally at 45 mg daily, on continuous schedule
2: Experimental descriptive: non-adenocarcinoma histology	Drug: PF-00299804 PF-00299804 orally at 45 mg daily, on continuous schedule

Eligibility

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

Criteria

Inclusion Criteria:

Advanced NSCLC
Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment.
Measurable disease .
ECOG Performance status 0-2

Exclusion Criteria:

Chemotherapy
Radiotherapy
Biological or investigational agents within 4 weeks of baseline disease assessment.
Patients who lack of tolerance of erlotinib therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548093

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, California
	Pfizer Investigational Site	Recruiting
	Duarte, California, United States, 91010
	Pfizer Investigational Site	Recruiting
	Pasadena, California, United States, 91105

United States, Colorado
	Pfizer Investigational Site	Recruiting
	Aurora, Colorado, United States, 80045

United States, Maryland
	Pfizer Investigational Site	Recruiting
	Bethesda, Maryland, United States, 20892

United States, Massachusetts
	Pfizer Investigational Site	Recruiting
	Boston, Massachusetts, United States, 02114
	Pfizer Investigational Site	Recruiting
	Boston, Massachusetts, United States, 02115
	Pfizer Investigational Site	Recruiting
	Boston, Massachusetts, United States, 02215

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:	A7471002
First Received:	October 19, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00548093
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

non-small cell lung cancer, advanced, previously treated

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

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00548093