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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00059722

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: ZD6474 Drug: Placebo Drug: ZD1839	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: ZD1839 Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	160
Study Start Date:	April 2005
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059722

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Locations

United States, Arkansas
Research Site
Pine Bluff, Arkansas, United States
United States, California
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
Palm Springs, California, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
Research Site
Boca Raton, Florida, United States
Research Site
Orange Park, Florida, United States
United States, Idaho
Research Site
Coeur d'Alene, Idaho, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
Research Site
St. Loius, Missouri, United States
United States, New York
Research Site
New York, New York, United States
Research Site
Brooklyn, New York, United States
United States, North Carolina
Research Site
Greenville, North Carolina, United States
United States, North Dakota
Research Site
Bismarck, North Dakota, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Argentina
Research Site
Buenos Aires, Argentina
Research Site
Mendoza, Argentina
Belgium
Research Site
Liege, Belgium
Research Site
Wilrijk, Belgium
Research Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Brussels (Jette), Belgium
Research Site
Brussels (Woluwé-St-Lambert), Belgium
Germany
Research Site
Essen, Germany
Research Site
Hamburg, Germany
Research Site
Berlin, Germany
Research Site
Mainz, Germany
Germany, Nordrhein-Westfalen
Research Site
Essen, Nordrhein-Westfalen, Germany
Germany, Rheinland-Pfalz
Research Site
Mainz, Rheinland-Pfalz, Germany
Germany, SUNDERLAND
Research Site
Ryhope, SUNDERLAND, Germany
South Africa
Research Site
Durban, South Africa
Research Site
Pretoria, South Africa
Research Site
Bloemfontein, South Africa
Research Site
Port Elizabeth, South Africa
Research Site
Parktown, South Africa
Research Site
Cape Town, South Africa
Research Site
Johannesburg, South Africa
Research Site
Lyttelton Manor, South Africa
United Kingdom
Research Site
Edinburgh, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Leeds, United Kingdom
United Kingdom, Middlesex
Research Site
Northwood, Middlesex, United Kingdom
United Kingdom, South Glamorgan
Research Site
Cardiff, South Glamorgan, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Oncology Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	6474IL/0003
Study First Received:	May 2, 2003
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00059722 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

NSCLC
locally advanced or metastatic
second-line

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009