This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC. - Tabular View

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This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

This study has been completed.

Study NCT00059722. Last updated on October 5, 2005. Information provided by AstraZeneca

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

Descriptive Information Fields

Brief Title ^†

This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

Official Title ^†

A Phase II, Randomized Double-Blind, 2-Part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-Small Cell Lung Cancer After Failure of First-Line Platinum-Based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.

Brief Summary

The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

Primary Outcomes:
Part A
i. Time to progression
ii. Incidence, CTC grade and type of Aes, clinicallyl significant laboratory abnormalities or changes in vital signs, and ECG changes
Part B

Secondary Outcome Measure ^†

Secondary Outcomes:
Part A
i. Objective response
ii. Disease control at 8 weeks
iii. Time to death
iv. WHO performance status
v. QOL and LCS from the FACT-L questionnaire
Part B
i. Objective response in subjects following treatment with the alternate study treatment
ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
iii. WHO performance status in subjects following treatment with the alternate study treatment
iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment

Condition ^†

Carcinoma, Non-Small-Cell Lung

Intervention ^†

Drug: ZD6474
Drug: Placebo
Drug: ZD1839

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

160

Start Date ^†

April 2005

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria:

Subjects who have received second-line or subsequent chemotherapy
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Belgium, Germany, South Africa, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00059722

Organization ID

6474IL/0003

Secondary IDs ^††

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

AstraZeneca Oncology Medical Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

October 2005

First Received Date ^†

May 2, 2003

Last Updated Date

October 5, 2005

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