Iressa Follow-up Trial

NCT00357734 | Completed Phase 3 Results

• 2 other identifiers: 1839IL/0555D7913L00008
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Lung Cancer; Breast Cancer

Keywords

lung cancer; breast cancer

Outcome Measures

Primary Outcomes (4)

• Number of Serious Adverse Events (SAEs)

  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

  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)

• Number of Serious Adverse Events (SAEs) Related to ZD1839

  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.

  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)

• Number of Other Adverse Events (AEs)

  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.

  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)

• Number of Other Adverse Events (AEs) Related to ZD1839

  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.

  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)

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  From randomization until progression or death (up to 120 months)

• Overall Survival (OS)

  From randomization until death (up to 120 months)

Study Arms (1)

Gefitinib (ZD1839)

EXPERIMENTAL

ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Drug: Gefitinib

Interventions

Gefitinib DRUG

ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Gefitinib (ZD1839)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Freiburg im Breisgau, Germany

Location

Research Site

Gauting, Germany

Location

Research Site

Großhansdorf, Germany

Location

Research Site

Hemer, Germany

Location

Research Site

Jena, Germany

Location

Research Site

Minden, Germany

Location

Research Site

Tübingen, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was stopped after enrolling 14 of 100 patients. The outcome was biased by the limited number of patients. Therefore, data allow only a limited statement on efficacy and long term safety.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• AstraZeneca Germany Medical Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: January 1, 2005
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 30, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-06

Locations

DE (7)