Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer. - Full Text View

Purpose

To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Erlotinib Erlotinib hydrochloride ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase 1/2, Open Label, Single Arm Trial To Determine The Recommended Phase 2 Dose And Evaluate The Efficacy Of Pf 00299804 In Patients In Korea With Kras Wild Type Advanced NSCLC, Which Is Refractory To Chemotherapy And Erlotinib Or Gefitinib

Further study details as provided by Pfizer:

Primary Outcome Measures:

Phase 2- Overall response according to Response Evaluation Criteria in Solid Tumors. [ Time Frame: 04-DEC-2009 ] [ Designated as safety issue: No ]
Endpoints- Phase 1- Recommended phase 2 dose. [ Time Frame: 30-AUG-2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression -free survival at 6 months [ Time Frame: 30-JAN-2010 ] [ Designated as safety issue: No ]
Overall survival at 6 months [ Time Frame: 30-JAN-2010 ] [ 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: 30-JAN-2010 ] [ Designated as safety issue: Yes ]
Phase 1- Single and multiple dose pharmacokinetic parameters of PF_00299804 [ Time Frame: 30-MAR-2009 ] [ Designated as safety issue: No ]
Phase 2-Duration of overall response [ Time Frame: 30-JAN-2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PF-00299804 Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent

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 or gefitinib.
Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment.
Measurable disease .

Exclusion Criteria:

Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment. Patients who lack of tolerance of erlotinib therapy.
Patient with known brain Metastases
Patients with demonstrated history of or presence of interstitial lung disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553254

Contacts


Contact: Pfizer Oncology Clinical Trial Information Services	1-877-369-9753	PfizerCancerTrial@emergingmed.com

Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


Korea, Republic of
	Pfizer Investigational Site	Recruiting
	Seoul, Korea, Republic of, 110-744
	Pfizer Investigational Site	Recruiting
	Seoul, Korea, Republic of, 135-710
	Pfizer Investigational Site	Recruiting
	Seoul, Korea, Republic of, 120-752

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:	A7471003
First Received:	November 2, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00553254
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Erlotinib

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Gefitinib

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 07, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00553254