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An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684385
First Posted: May 26, 2008
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Condition Intervention Phase
Non Small Cell Lung Cancer Cancer of the Head and Neck Drug: ZD1839 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • There are no endpoints in this Expanded Access programme. No formal analysis will be performed on any data obtained. All safety data will be tabulated for reporting purposes only. [ Time Frame: There are no endpoints ]

Enrollment: 264
Actual Study Start Date: August 8, 2001
Estimated Study Completion Date: December 29, 2017
Estimated Primary Completion Date: December 29, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ZD1839
250mg administered daily for patients with NSCLC and500mg daily for patients with H&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H&NC will take two tablets at each dose administration.
Other Name: Iressa

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have received at least one course of standard systemic chemotherapy or radiation therapy
  • Are ineligible for chemotherapy or radiotherapy
  • Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC
  • Are, in the investigators opinion, not medically suitable for chemotherapy.

Exclusion Criteria:

  • Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
  • Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
  • Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
  • Incomplete healing from prior oncologic or other major surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684385


Locations
Germany
Research Site
Berlin, Germany, 10117
Research Site
Berlin, Germany, 13125
Research Site
Berlin, Germany, 14165
Research Site
Essen, Germany, 45122
Research Site
Frankfurt, Germany, 60590
Research Site
Freiburg, Germany, 79106
Research Site
Großhansdorf, Germany, 22927
Research Site
Göttingen, Germany, 37075
Research Site
Halle, Germany, 06112
Research Site
Halle, Germany, 06120
Research Site
Heidelberg, Germany, 69126
Research Site
Kiel, Germany, 24105
Research Site
Löwenstein, Germany, 74245
Research Site
Mainz, Germany, 55131
Research Site
München, Germany, 81675
Research Site
Nürnberg, Germany, 90419
Research Site
Oldenburg, Germany, 26121
Research Site
Oldenburg, Germany, 26133
Research Site
Stuttgart, Germany, 70174
Research Site
Trier, Germany, 54292
Research Site
Wiesbaden, Germany, 65199
Hungary
Research Site
Budapest, Hungary, 1121
Research Site
Budapest, Hungary, 1122
Research Site
Budapest, Hungary, 1125
Research Site
Kecskemét, Hungary, 6000
Research Site
Törökbálint, Hungary, 2045
Poland
Research Site
Gdańsk, Poland, 80-952
Research Site
Warszawa, Poland, 02-781
Research Site
Zabrze, Poland, 41-803
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Haiyi Jiang AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00684385     History of Changes
Other Study ID Numbers: 1839IL/0052
D7914C00052
First Submitted: May 21, 2008
First Posted: May 26, 2008
Last Update Posted: July 26, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action