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

• ClinicalTrials.gov Identifier: NCT00074854
• Recruitment Status: Completed
• First Posted: December 24, 2003
• Last Update Posted: November 9, 2006
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: December 22, 2003
• First Posted Date: December 24, 2003
• Last Update Posted Date: November 9, 2006
• Study Start Date: May 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: July 28, 2006): 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.
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: July 28, 2006): Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Neoplasms
• Intervention: Drug: CP-547,632
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 87
• Original Enrollment: Same as current
• Study Completion Date: March 2005
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00074854
• Other Study ID Numbers: A3521002
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2006