Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00364351

Purpose

To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Vandetanib Drug: Erlotinib	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Demonstrate an improvement in Progression Free Survival for ZD6474 compared with erlotinib in patients with locally advanced or metastatic NSCLC after failure of at least one but no more than two, prior chemotherapy regimes. [ Time Frame: time to progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To demonstrate an overall improvement in survival for ZD6474 compared with erlotinib [ Time Frame: time to death ] [ Designated as safety issue: No ]

Enrollment:	1243
Study Start Date:	August 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Erlotinib	Drug: Erlotinib oral dose
2: Experimental Vandetanib	Drug: Vandetanib once daily oral tablet

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed locally advanced or metastatic NSCLC
Failure of at least one but not more than two prior chemotherapy regimens

Exclusion Criteria:

Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar)
Chemotherapy or other type of anti cancer therapy within 4 weeks of study start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364351

Show 179 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

ZD6474 Medical Science Director, MD

AstraZeneca

More Information

Responsible Party:	AstraZeneca ( Peter Langmuir )
Study ID Numbers:	D4200C00057, EUDRACT No. 2006-000259-16
Study First Received:	August 14, 2006
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00364351
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Non Small Cell Lung Cancer
NSCLC

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009