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An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-small-cell Lung, Metastases, Neoplasm

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Trial Information

An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria


Inclusion Criteria

For inclusion in this trial, patients must fulfill all of the following criteria:

- previous documented histologically or cytologically confirmed non-small cell lung
cancer;

- locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III
or IV)patients who have received at least one course of standard systemic
chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy
or are ineligible or not a candidate for enrollment on another ZD1839 trial or who,
in the Investigator's opinion, are not medically suitable for chemotherapy.

- age 18 years or older;

- written informed consent to participate in the trial.

Exclusion Criteria

Any of the following will exclude a patient from entering the trial:

- receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer
medication or any other investigational agent. * Non-cytotoxic or hormonal
therapies for the adjuvant treatment of cancer or for previously treated cancers may
be allowed per AstraZeneca permission;

- patients eligible for or previously enrolled on a ZD1839 blinded clinical trial
protocol. Patients eligible for or previously enrolled on an open-label or unblinded
ZD1839 clinical trial may be considered for acceptance into the Expanded Access
Program with AstraZeneca permission;

- having other active malignancies;

- incomplete healing from previous oncologic or other major surgery;

- evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the trial;

- pregnancy or breast feeding (women of child-bearing potential).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Iressa Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

1839IL/0050

NCT ID:

NCT00034879

Start Date:

August 2000

Completion Date:

October 2003

Related Keywords:

  • Carcinoma
  • Non-Small-Cell Lung
  • Metastases
  • Neoplasm
  • Locally advanced and/or metastatic non-operable
  • non-small cell lung cancer (stage III or IV)
  • patients who have failed standard therapy.
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnchorage, Alaska  
Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteLewes, Delaware  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteHonolulu, Hawaii  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAmes, Iowa  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteHattiesburg, Mississippi  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteEnid, Oklahoma  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteCharleston, South Carolina  
Research SiteAberdeen, South Dakota  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteBennington, Vermont  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteClarksburg, West Virginia  
Research SiteAppleton, Wisconsin  
Research SiteCheyenne, Wyoming