ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) - Tabular View

Tracking Information

First Received Date ^ICMJE

October 14, 2003

Last Updated Date

April 9, 2009

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00071188 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Official Title ^ICMJE

A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Brief Summary

The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: ZD6474
Drug: Paclitaxel
Drug: Carboplatin

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

Completed

Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed informed consent
18 years or older
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
No prior chemotherapy/biological therapy/radiation therapy
One or more measurable lesions
Life expectancy more than 12 weeks

Exclusion Criteria:

Brain metastases or spinal cord compression
Currently active skin disease
History of significant hemoptysis
Abnormal blood chemistry
Cardiac abnormalities
Recent significant cardiac event
Coexisting malignancies

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

United States, Finland, France, Germany, India, Italy, South Africa, Spain, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00071188

Responsible Party

Study ID Numbers ^ICMJE

D4200C00007, D4200C00007(run-in), D4200C0007A (randomization)

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca ZD6474 Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

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