This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-Small Cell Lung Cancer. - Full Text View

Purpose

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

Condition	Intervention	Phase
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-Line	Drug: ZD6474 Drug: Placebo Drug: Docetaxel	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Docetaxel Vandetanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-Based Chemotherapy.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Outcome Progression free survival

Secondary Outcome Measures:

Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
Objective response rate and duration of response
QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
WHO performance status
Time to death

Estimated Enrollment:	129
Study Start Date:	October 2002
Study Completion Date:	September 2006

Eligibility

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

Criteria

Inclusion Criteria:

Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
Failure of first-line platinum-based chemotherapy

Exclusion Criteria:

Mixed small cell or non-small-cell histology
Bronchoalveolar carcinoma
Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
Prior treatment with docetaxel

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047840

Show 26 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	ZD6474 Medical Science Director, MD	AstraZeneca

More Information

Study ID Numbers:	6474IL/0006
First Received:	October 18, 2002
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00047840
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel

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

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00047840