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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00684385
First received: May 21, 2008
Last updated: June 11, 2014
Last verified: June 2014
  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 (NSCLC)
Cancer of the Head and Neck (H&N)
Drug: ZD1839
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Enrollment: 269
Study Start Date: August 2001
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00684385

Locations
Germany
Research Site
Berlin, Germany
Research Site
Essen, Germany
Research Site
Frankfurt, Germany
Research Site
Freiburg, Germany
Research Site
Großhansdorf, Germany
Research Site
Göttingen, Germany
Research Site
Halle, Germany
Research Site
Heidelberg, Germany
Research Site
Kiel, Germany
Research Site
Löwenstein, Germany
Research Site
Mainz, Germany
Research Site
München, Germany
Research Site
Nürnberg, Germany
Research Site
Oldenburg, Germany
Research Site
Stuttgart, Germany
Research Site
Trier, Germany
Research Site
Wiesbaden, Germany
Hungary
Research Site
Budapest, Hungary
Research Site
Kecskemét, Hungary
Research Site
Törökbálint, Hungary
Poland
Research Site
Gdańsk, Poland
Research Site
Warszawa, Poland
Research Site
Zabrze, Poland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Haiyi Jiang AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00684385     History of Changes
Other Study ID Numbers: 1839IL/0052, D7914C00052
Study First Received: May 21, 2008
Last Updated: June 11, 2014
Health Authority: China: Ethics Committee
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration
Portugal: Ethics Committee for Clinical Research
Slovakia: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on July 24, 2014