NCT00074854

Brief Summary

The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2002

Typical duration for phase_1

Geographic Reach
1 country

20 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2002

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

November 9, 2006

Status Verified

July 1, 2006

First QC Date

December 22, 2003

Last Update Submit

November 8, 2006

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.

Secondary Outcomes (1)

  • Given the outcome of the primary objective, analysis of secondary objectives were not formalized.

Interventions

CP-547,632DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
  • Bidimensionally measurable disease \>2cm x 1 cm by conventional CT Scan or \>1 cm x 1cm by spiral CT Scan.

You may not qualify if:

  • No tumors in close proximity to major veins or arteries.
  • No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
  • No evidence or history brain metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pfizer Investigational Site

Greenbrae, California, 94904, United States

Location

Pfizer Investigational Site

San Mateo, California, 94402, United States

Location

Pfizer Investigational Site

San Pablo, California, 94806, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612-9497, United States

Location

Pfizer Investigational Site

Covington, Louisiana, 70433, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, 70002, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, 70006, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Stony Brook, New York, 11794, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Gallatin, Tennessee, 37066, United States

Location

Pfizer Investigational Site

Hermitage, Tennessee, 37076, United States

Location

Pfizer Investigational Site

Lebanon, Tennessee, 37087, United States

Location

Pfizer Investigational Site

Murfreesboro, Tennessee, 37130, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37205, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37207, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37211, United States

Location

Pfizer Investigational Site

Smyrna, Tennessee, 37167, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

3-(4-bromo-2,6-difluorobenzyloxy)-5-(3-(4-pyrrolidin-1-ylbutyl)ureido)isothiazole-4-carboxylic acid amide

Condition Hierarchy (Ancestors)

Respiratory 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2003

First Posted

December 24, 2003

Study Start

May 1, 2002

Study Completion

March 1, 2005

Last Updated

November 9, 2006

Record last verified: 2006-07

Locations

US(20)