Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00971191
First received: September 2, 2009
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

This study will enroll patients who are planned to undergo surgical removal of their tumor. The goal of the study is to evaluate the changes that occur in the tumor after brief (about 8 days) exposure to the study drug.


Condition Intervention Phase
Non-Small Cell Lung Cancer (NSCLC)
Drug: PF-00299804
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Presurgical Study To Evaluate Molecular Changes That Occur In Human Non-Small Cell Lung Cancer Tissue After Short Term Exposure To PF-00299804

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To identify the molecular changes which occur in human non-small cell lung cancer tissue after short-term exposure to PF-00299804 administered at 45 mg daily after a loading dose [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate molecular changes with specific gene and protein changes (eg, mutations, amplifications, over expression) in members of the EGFR and HER2 signal transduction pathways (eg, KRAS, EGFR, HER2) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • To assess the effect of short term treatment of PF-00299804 on serum levels of the extracellular domain of EGFR and other serum markers of HER signaling (eg, serum HER2/neu and serum E-cadherin) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of PF-00299804 in this setting [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
Patients treated with brief exposure to PF-00299804 prior to surgical resection
Drug: PF-00299804
Brief exposure (5- 11 days) to study drug prior to surgical resection

Detailed Description:

The A7471031 study was terminated on May 2, 2012. The decision for unplanned study termination was triggered by feasibility of further conduct of this trial as only 22 of the protocol-specified 75 patients were enrolled since the study initiated in February 2010. Based on this low accrual rate it was determined that the study was highly unlikely to complete accrual and provide meaningful data. The discontinuation of the study is not due to any safety issue.

  Eligibility

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

Inclusion Criteria:

  • Radiographs consistent with lung cancer for which resection is indicated upon histologic confirmation of non-small cell lung cancer.
  • Patient willing to take PF-00299804 for 5 to 11 days and provide blood and tissue specimens as required in the study.

Exclusion Criteria:

  • Prior or concurrent systemic anticancer therapy for cancer (immunotherapy, hormonotherapy, biological therapy, or chemotherapy) less than one year from time of consent.
  • Prior or concurrent radiation therapy to tumor at site of planned resection.
  • Congestive heart failure (LVEF < 50%), uncontrolled hypertension, significant ventricular arrythmia.
  • Drugs that are highly dependent on CYP2D6 for metabolism, or are generally accepted to have a risk of causing Torsades de Pointes.
  • Prior or concurrent radiation therapy to tumor at site of planned resection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971191

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00971191     History of Changes
Other Study ID Numbers: A7471031
Study First Received: September 2, 2009
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Stage I - III surgical resection molecular change brief pre-operative exposure

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014