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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

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ClinicalTrials.gov Identifier: NCT00684385
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

May 21, 2008
May 26, 2008
December 18, 2017
August 8, 2001
September 16, 2014   (Final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00684385 on ClinicalTrials.gov Archive Site
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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
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)
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non Small Cell Lung Cancer
  • Cancer of the Head and Neck
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
Experimental: 1
Intervention: Drug: ZD1839
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
264
September 16, 2014
September 16, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Poland
 
 
NCT00684385
1839IL/0052
D7914C00052
Not Provided
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AstraZeneca
AstraZeneca
Not Provided
Study Director: Haiyi Jiang AstraZeneca
AstraZeneca
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP