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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00321815
First received: May 3, 2006
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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 ]

Enrollment: 43
Study Start Date: August 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Active Comparator: B
Standard of Care chemotherapy
 Drug: Erlotinib
Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
Other Name: Tarceva

  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 35 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: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00321815     History of Changes
Other Study ID Numbers: A8501006
Study First Received: May 3, 2006
Last Updated: December 16, 2010
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:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013