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Completed

NCT Number: NCT00357734

Iressa Follow-up Trial

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

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Freiburg im Breisgau, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. Overall Survival (OS)

    Time frame: From randomization until death (up to 120 months)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials.

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2006
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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