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

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

This study has been completed.

Study NCT00071188. Last updated on November 2, 2007. Information provided by AstraZeneca

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

Descriptive Information Fields

Brief Title ^†

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 ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Carcinoma, Non-Small-Cell Lung

Intervention ^†

Drug: ZD6474
Drug: Paclitaxel
Drug: Carboplatin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 2004

Completion Date

September 2007

Eligibility Criteria ^†

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 ^††

Location Countries ^†

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

Administrative Information Fields

NCT ID ^†

NCT00071188

Organization ID

D4200C00007

Secondary IDs ^††

D4200C00007(run-in), D4200C0007A (randomization)

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

AstraZeneca ZD6474 Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

November 2007

First Received Date ^†

October 14, 2003

Last Updated Date

November 2, 2007

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