A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel. - Tabular View

Tracking Information

First Received Date ^ICMJE

October 6, 2006

Last Updated Date

June 6, 2007

Start Date ^ICMJE

May 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00386555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
Evaluate the PK of CP 868,596 when given in combination with docetaxel
Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373

Original Secondary Outcome Measures ^ICMJE

Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
Evaluate the PK of CP 868,596 when given in combination with docetaxel
Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 013736

Descriptive Information

Brief Title ^ICMJE

A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

Official Title ^ICMJE

Phase 2 Study of CP-868,596 + Docetaxel, AG-013736 + Docetaxel, or CP-868,596 + AG-013736 + Docetaxel and of Docetaxel Alone in Patients With Stage IIIb or IV Non-Small Cell Lung Cancer.

Brief Summary

To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung cancer.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: docetaxel
Drug: CP-868,596 + docetaxel
Drug: AG-013736 + docetaxel
Drug: CP-868,596 + AG-013736 + docetaxel

Study Arms / Comparison Groups

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 ^ICMJE

Withdrawn

Enrollment ^ICMJE

139

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Platinum-pretreated patients with advanced stage IIIb or IV NSCLC

Exclusion Criteria:

Centrally-located tumors

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00386555

Responsible Party

Study ID Numbers ^ICMJE

A5301010

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP