ZD6474 Phase IIa Dose Finding Multicentre Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252746

Purpose

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Condition	Intervention	Phase
Non Small Cell Lung Carcinoma	Drug: ZD6474 (vandetanib)	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Vandetanib

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Parallel-Group, Dose Finding Study to Assess the Efficacy and Safety of ZD6474 in Patients With Advanced, Metastatic, or Recurrent NSCLC Who Have Failed Previous Chemotherapy Regimens, at Least One of Which Contained Platinum [Title Abbreviated]

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Secondary Outcome Measures:

To assess the tolerability, safety, disease control rate, duration of response, time to progression, changes in quality of life and tumour-related and overall symptom improvements, and to characterise the PK and PK-PD relationship

Intervention Details:

once daily oral dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Pregnancy, breast feeding or female patients wishing to become pregnant.
Treatment with a non-approved or investigational drug within 30 days before enrolment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252746

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Japan Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D4200C00039
Study First Received:	November 14, 2005
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00252746
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

NSCLC
Non Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Signs and Symptoms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

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

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009