First-Line Treatment for Adenocarcinoma Patients With EGFR Mutation - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00344773

Purpose

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Condition	Intervention	Phase
Pulmonary Cancer	Drug: Gefitinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label, Multi-Centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-Line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With EGFR Mutation.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Objective response rate(ORR) based on RECIST criteria [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: time to progression and death ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: time to progression and death ] [ Designated as safety issue: No ]
Safety profile (type, frequency and severity of adverse events, Laboratory parameters and vital signs) according to NCI CTCAE version 3.0 [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	145
Study Start Date:	March 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

oral tablet

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
WHO Performance Status 0-2
No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

Any evidence of clinically active interstitial lung disease
Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344773

Locations

Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Seongnam-Si, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

HyeJong Yoo

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D7913L00056
Study First Received:	June 26, 2006
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00344773 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation
Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation
Recurrent pulmonary adenocarcinoma with EGFR mutation

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma

Protein Kinase Inhibitors
Gefitinib
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

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
Adenocarcinoma
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009