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A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CP-547,632
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
December 22, 2003
Last Updated
November 8, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00074854
Brief Title
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy
Official Title
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-547,632
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Given the outcome of the primary objective, analysis of secondary objectives were not formalized.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Pfizer Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94402
Country
United States
Facility Name
Pfizer Investigational Site
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Pfizer Investigational Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Pfizer Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pfizer Investigational Site
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Pfizer Investigational Site
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37087
Country
United States
Facility Name
Pfizer Investigational Site
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Pfizer Investigational Site
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3521002&StudyName=A+Clinical+Efficacy+Study+Of+An+Oral+Tyrosine+Kinase+Inhibitor+Of+VEGFR%2D2+Given+In+Combination+With+Chemotherapy
Description
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A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy

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