Iressa Follow-up Trial - Full Text View

Purpose

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).

Condition	Intervention	Phase
Lung Cancer Breast Cancer	Drug: Gefitinib	Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lung cancer

Drug Information available for: Gefitinib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of Serious Adverse Events (SAEs) [ Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) ]
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease
Number of Serious Adverse Events (SAEs) Related to ZD1839 [ Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) ]
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Number of Other Adverse Events (AEs) [ Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) ]
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Number of Other Adverse Events (AEs) Related to ZD1839 [ Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months) ]
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.

Secondary Outcome Measures:

Progression-free Survival (PFS) [ Time Frame: From randomization until progression or death (up to 120 months) ]
Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (OS) [ Time Frame: From randomization until death (up to 120 months) ]


Enrollment:	14
Study Start Date:	January 2005
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gefitinib (ZD1839) ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial	Drug: Gefitinib ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Eligibility


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of written informed consent to participate in the trial.
Female or male aged 18 years and over.
Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation

Exclusion Criteria:

Known severe hypersensitivity to ZD1839
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
Withdrawal from a parent ZD1839 trial because of tumor progress

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357734

Locations


Germany
Research Site
Freiburg, Germany
Research Site
Gauting, Germany
Research Site
Großhansdorf, Germany
Research Site
Hemer, Germany
Research Site
Jena, Germany
Research Site
Minden, Germany
Research Site
Tübingen, Germany

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Germany Medical Director, MD	AstraZeneca

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00357734 History of Changes
Other Study ID Numbers:	1839IL/0555 D7913L00008
Study First Received:	July 26, 2006
Results First Received:	May 17, 2016
Last Updated:	August 29, 2016

Keywords provided by AstraZeneca:


lung cancer breast cancer

Additional relevant MeSH terms:


Gefitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 17, 2017