Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00321815

Purpose

To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: PF-3512676 + Erlotinib Drug: Erlotinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive 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 [ Time Frame: 50Events ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Safety Profile [ Time Frame: 28 days post treatment ] [ Designated as safety issue: Yes ]
Time to Tumor Progression [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Overall Objective Response Rate [ Time Frame: Time of disease progression ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Time of disease progression ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Time of death ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Standard of Care chemotherapy plus experimental intervention (PF-3512676)	Drug: PF-3512676 + Erlotinib PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
B: Active Comparator Standard of Care chemotherapy	Drug: Erlotinib Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity

Eligibility

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

Criteria

Inclusion Criteria:

Advanced, EGFR-positive NSCLC
ECOG Performance Status 0, 1 or 2
Measurable disease

Exclusion Criteria:

Known CNS metastasis
Pre-existing autoimmune or antibody mediated disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321815

Show 34 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 Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8501006
Study First Received:	May 3, 2006
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00321815 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010