A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 3, 2008

Last Updated Date

May 8, 2009

Start Date ^†

April 2008

Current Primary Outcome Measures ^†

Progression Free Survival [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00600821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Population PK [ Time Frame: 2.5 yrs ] [ Designated as safety issue: Yes ]
Molecular profiling and biomarkers [ Time Frame: 2.5 yrs ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
Overall confirmed objective response rate [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
Overall safety profile [ Time Frame: 2.5 yrs ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

Official Title ^†

Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer

Brief Summary

To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Non-Small-Cell Lung Carcinoma
Adenocarcinoma

Intervention ^†

Drug: Bevacizumab + Carboplatin + Paclitaxel
Drug: AG-013736 (axitinib) + Carboplatin + Paclitaxel

Study Arms / Comparison Groups

Active Comparator: Bevacizumab will be given with carboplatin and paclitaxel, every 3 weeks.
Experimental: AG-013736 will be given with carboplatin and paclitaxel, every 3 weeks.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

108

Estimated Completion Date

April 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Advanced non squamous cell, lung cancer
No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment

Exclusion Criteria:

Prior therapy for advanced lung cancer
The need for blood-thinners
Coughing up blood

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Location Countries ^†

United States, Czech Republic, France, Poland, Spain, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600821

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.