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

Phase 1

Completed

• Conditions: Lung Neoplasms

• Registration Number: NCT00074854
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2003-12-22
• Study First Submitted QC: 2003-12-23
• Study First Posted: 2003-12-24
• Study Completion: 2005-03
• Status Verified: 2006-07
• Last Update Submitted: 2006-11-08
• Last Update Posted: 2006-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Smyrna, Tennessee, United States