NCT00971191

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

2.2 years

First QC Date

September 2, 2009

Last Update Submit

June 21, 2012

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Keywords

Stage I - III surgical resection molecular change brief pre-operative exposure

Outcome Measures

Primary Outcomes (1)

  • 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

    30 months

Secondary Outcomes (4)

  • 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)

    30 months

  • 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)

    30 months

  • To assess the relationship between the pharmacokinetic parameters with molecular changes detected in non-small cell lung cancer

    30 months

  • To assess the safety and tolerability of PF-00299804 in this setting

    30 months

Study Arms (1)

treatment

EXPERIMENTAL

Patients treated with brief exposure to PF-00299804 prior to surgical resection

Drug: PF-00299804

Interventions

PF-00299804DRUG

Brief exposure (5- 11 days) to study drug prior to surgical resection

treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

February 1, 2010

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations

US(3)