CarcinomaPhase 3NCT00034879

Iressa Expanded Access Program (EAP)

A Phase 3 study testing ZD1839 (Gefitinib) in people with Carcinoma and Non-small-cell Lung, run by AstraZeneca at 626 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-small-cell Lung, Metastases
What is being tested?: ZD1839 (Gefitinib)
How many people: Not given
Where: 626 sitesUnited States
Study dates: Aug 2000to Oct 2003
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

626 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

United States300 sites

Research Site
Aberdeen, South Dakota
Research Site
Abilene, Texas
Research Site
Abington, Virginia
Research Site
Akron, Ohio
Research Site
Alabaster, Alabama
Research Site
Albany, Georgia
Research Site
Albany, New York
Research Site
Albuquerque, New Mexico
Research Site
Alexandria, Minnesota
Research Site
Allentown, Pennsylvania
Research Site
Amarillo, Texas
Research Site
Ames, Iowa
Research Site
Anaheim, California
Research Site
Anchorage, Alaska
Research Site
Anniston, Alabama
Research Site
Appleton, Wisconsin
Research Site
Arcadia, California
Research Site
Arlington, Texas
Research Site
Arlington Heights, Illinois
Research Site
Asheville, North Carolina
Research Site
Ashland, Kentucky
Research Site
Athens, Georgia
Research Site
Atlanta, Georgia
Research Site
Auburn, Washington
Research Site
Aurora, Illinois
Research Site
Austin, Texas
Research Site
Bakersfield, California
Research Site
Baldwin Park, California
Research Site
Baltimore, Maryland
Research Site
Bangor, Maine
Research Site
Barberton, Ohio
Research Site
Baton Rouge, Louisiana
Research Site
Battle Kreek, Michigan
Research Site
Bay City, Michigan
Research Site
Bay Shore, New York
Research Site
Bayside, New York
Research Site
Baytown, Texas
Research Site
Beaumont, Texas
Research Site
Belleville, Illinois
Research Site
Belleville, New Jersey
Research Site
Bellflower, California
Research Site
Bemidji, Minnesota
Research Site
Bend, Oregon
Research Site
Bennington, Vermont
Research Site
Bentonville, Arkansas
Research Site
Berkeley, California
Research Site
Berwyn, Illinois
Research Site
Bethesda, Maryland
Research Site
Bethlehem, Pennsylvania
Research Site
Bettendorf, Iowa
Research Site
Beverly, Massachusetts
Research Site
Billings, Montana
Research Site
Birmingham, Alabama
Research Site
Bismarck, North Dakota
Research Site
Bloomington, Indiana
Research Site
Boca Raton, Florida
Research Site
Boise, Idaho
Research Site
Boone, North Carolina
Research Site
Boston, Massachusetts
Research Site
Boulder, Colorado
Research Site
Boynton Beach, Florida
Research Site
Bradenton, Florida
Research Site
Brainerd, Minnesota
Research Site
Branson, Missouri
Research Site
Bremerton, Washington
Research Site
Brockton, Massachusetts
Research Site
Bronxville, New York
Research Site
Brooklyn, New York
Research Site
Brunswick, Georgia
Research Site
Bryan, Ohio
Research Site
Bryan, Texas
Research Site
Bryn Mawr, Pennsylvania
Research Site
Buffalo, New York
Research Site
Burbank, California
Research Site
Burlington, Massachusetts
Research Site
Burlington, North Carolina
Research Site
Butler, Pennsylvania
Research Site
Camden, Arkansas
Research Site
Campbell, California
Research Site
Canton, Georgia
Research Site
Canton, Ohio
Research Site
Carrollton, Georgia
Research Site
Cellarsville, Pennsylvania
Research Site
Champaign, Illinois
Research Site
Charleston, South Carolina
Research Site
Charlotte, North Carolina
Research Site
Charlottesville, Virginia
Research Site
Chattanooga, Tennessee
Research Site
Chesapeake, Virginia
Research Site
Chesterfield, Missouri
Research Site
Cheyenne, Wyoming
Research Site
Chicago, Illinois
Research Site
Chicago Heights, Illinois
Research Site
Chico, California
Research Site
Chicopee, Massachusetts
Research Site
Chino, California
Research Site
Chule Vista, California
Research Site
Cincinnati, Ohio
Research Site
Clarksburg, West Virginia
Research Site
Clearwater, Florida
Research Site
Cleveland, Ohio
Research Site
Coeur d'Alene, Idaho
Research Site
Collierville, Tennessee
Research Site
Columbia, Missouri
Research Site
Columbia, South Carolina
Research Site
Columbus, Ohio
Research Site
Concord, California
Research Site
Concord, North Carolina
Research Site
Cooperstown, New York
Research Site
Coos Bay, Oregon
Research Site
Corpus Christi, Texas
Research Site
Corvallis, Oregon
Research Site
Creve Coeus, Missouri
Research Site
Cumberland, Maryland
Research Site
Dallas, Texas
Research Site
Danbury, Connecticut
Research Site
Danville, Illinois
Research Site
Danville, Kentucky
Research Site
Danville, Pennsylvania
Research Site
Danville, Virginia
Research Site
Davenport, Iowa
Research Site
Dayton, Ohio
Research Site
Daytona Beach, Florida
Research Site
Debque, Louisiana
Research Site
Decatur, Illinois
Research Site
Denver, Colorado
Research Site
Denville, New Jersey
Research Site
Des Moines, Iowa
Research Site
Des Plaines, Illinois
Research Site
Detroit, Michigan
Research Site
Drexel Hill, Pennsylvania
Research Site
Duarte, California
Research Site
Duluth, Minnesota
Research Site
Dunmore, Pennsylvania
Research Site
Durham, North Carolina
Research Site
East Setauket, New York
Research Site
East Stroudsburg, Pennsylvania
Research Site
East Syracuse, New York
Research Site
Easton, Pennsylvania
Research Site
Eau Claire, Wisconsin
Research Site
El Paso, Texas
Research Site
Elizabeth, New Jersey
Research Site
Elizabeth, North Carolina
Research Site
Elk Grove Village, Illinois
Research Site
Elmhurst, Illinois
Research Site
Englewood, New Jersey
Research Site
Enid, Oklahoma
Research Site
Ephrata, Pennsylvania
Research Site
Erie, Pennsylvania
Research Site
Eugene, Oregon
Research Site
Eureka, California
Research Site
Evanston, Illinois
Research Site
Evansville, Indiana
Research Site
Fairbanks, Alaska
Research Site
Fairfax, Virginia
Research Site
Fairfield, California
Research Site
Fairfield, Connecticut
Research Site
Fairfield, Ohio
Research Site
Fargo, North Dakota
Research Site
Farmington, New Mexico
Research Site
Fayetteville, North Carolina
Research Site
Finley, Ohio
Research Site
Flemington, New Jersey
Research Site
Flint, Michigan
Research Site
Florence, South Carolina
Research Site
Flossmore, Illinois
Research Site
Flushing, New York
Research Site
Fontana, California
Research Site
Forest City, North Carolina
Research Site
Fort Collins, Colorado
Research Site
Fort Gordon, Georgia
Research Site
Fort Myers, Florida
Research Site
Fort Smith, Arkansas
Research Site
Fort Wayne, Indiana
Research Site
Fort Worth, Texas
Research Site
Fountain Valley, California
Research Site
Franklin, Pennsylvania
Research Site
Fredericksburg, Virginia
Research Site
Fredricksburg, Texas
Research Site
Free Soil, Michigan
Research Site
Fresh Meadows, New York
Research Site
Fresno, California
Research Site
Fullerton, California
Research Site
Gadsen, Alabama
Research Site
Gainesville, Florida
Research Site
Galesburg, Illinois
Research Site
Galloway, New Jersey
Research Site
Garland, Texas
Research Site
Geneseo, New York
Research Site
Geneva, Illinois
Research Site
Gilroy, California
Research Site
Glen Cove, New York
Research Site
Glens Falls, New York
Research Site
Goldsboro, North Carolina
Research Site
Golfport, Michigan
Research Site
Goshen, New York
Research Site
Grand Forks, North Dakota
Research Site
Grand Island, Nebraska
Research Site
Grand Rapids, Michigan
Research Site
Grass Valley, California
Research Site
Great Falls, Montana
Research Site
Great Neck, New York
Research Site
Green Bay, Wisconsin
Research Site
Greenbrae, California
Research Site
Greensboro, North Carolina
Research Site
Greensburg, Pennsylvania
Research Site
Greenville, North Carolina
Research Site
Greenville, South Carolina
Research Site
Greenwich, Connecticut
Research Site
Grosse Point Woods, Michigan
Research Site
Hackensack, New Jersey
Research Site
Hampton, Virginia
Research Site
Handen, Connecticut
Research Site
Harris, New York
Research Site
Harrisburg, Pennsylvania
Research Site
Hartford, Connecticut
Research Site
Harvey, Illinois
Research Site
Hattiesburg, Mississippi
Research Site
Hays, Kansas
Research Site
Hazard, Kentucky
Research Site
Hazleton, Pennsylvania
Research Site
Helena, Montana
Research Site
Hickory, North Carolina
Research Site
Hinsdale, IL, Illinois
Research Site
Honolulu, Hawaii
Research Site
Hooksett, New Hampshire
Research Site
Houston, Texas
Research Site
Huntington, New York
Research Site
Huntington, West Virginia
Research Site
Huntington Station, New York
Research Site
Huntsville, Alabama
Research Site
Hutchinson, Kansas
Research Site
Idaho Falls, Idaho
Research Site
Independence, Ohio
Research Site
Indianapolis, Indiana
Research Site
Iowa City, Iowa
Research Site
Iron Mountain, Michigan
Research Site
Irving, Texas
Research Site
Ivins, Utah
Research Site
Jackson, Michigan
Research Site
Jackson, Mississippi
Research Site
Jackson, Tennessee
Research Site
Jacksonville, Florida
Research Site
Janesville, Wisconsin
Research Site
Jasper, Indiana
Research Site
Johnson City, New York
Research Site
Johnson City, Tennessee
Research Site
Joliet, Illinois
Research Site
Joplin, Missouri
Research Site
Jupiter, Florida
Research Site
Kalamazoo, Michigan
Research Site
Kansas City, Kansas
Research Site
Kansas City, Missouri
Research Site
Kennewick, Washington
Research Site
Kettering, Ohio
Research Site
Key West, Florida
Research Site
Kingston, Pennsylvania
Research Site
Kinston, North Carolina
Research Site
Kirkland, Washington
Research Site
Kittanning, Pennsylvania
Research Site
Klamath, Oregon
Research Site
Knoxville, Tennessee
Research Site
La Crosse, Wisconsin
Research Site
La Grange, Illinois
Research Site
La Jolla, California
Research Site
Lafayette, Louisiana
Research Site
Lake Charles, Louisiana
Research Site
Lake Success, New York
Research Site
Lake Worth, Florida
Research Site
Lakeland, Florida
Research Site
Lakewood, California
Research Site
Lancaster, Pennsylvania
Research Site
Langhorn, Pennsylvania
Research Site
Langhorne, Pennsylvania
Research Site
Lansing, Michigan
Research Site
Lapeer, Michigan
Research Site
Las Cruces, New Mexico
Research Site
Las Vegas, Nevada
Research Site
LaVerne, California
Research Site
Lawrence, Kansas
Research Site
Lawton, Oklahoma
Research Site
Lebanon, New Hampshire
Research Site
Leesburg, Florida
Research Site
Lemoyne, Pennsylvania
Research Site
Lenexa, Kansas
Research Site
Lewes, Delaware
Research Site
Lewisville, Texas
Research Site
Lexington, Kentucky
Research Site
Libertyville, Illinois
Research Site
Lincoln, Nebraska
Research Site
Little Rock, Arkansas
Research Site
Little Silver, New Jersey
Research Site
Livingston, New Jersey
Research Site
Loma Linda, California
Research Site
Long Beach, California
Research Site
Long Branch, New Jersey
Research Site
Longmont, Colorado
Research Site
Los Alamitos, California
Research Site
Los Angeles, California
Research Site
Los Gatos, California

Other trials in United States

About this study

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

A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

Conditions: Carcinoma, Non-small-cell Lung, Metastases, Neoplasm
Being tested: ZD1839 (Gefitinib)
Keywords: Locally advanced and/or metastatic non-operable, non-small cell lung cancer (stage III or IV), patients who have failed standard therapy.
Medical subject headings: Carcinoma, Neoplasm Metastasis, Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZD1839 (Gefitinib)Drug
Also called Iressa

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2000Oct 2003

First posted3 May 2002 (estimated)
Study startAug 2000
Primary completionOct 2003
Study completionOct 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CarcinomaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00034879
Sponsor's protocol ID: 1839IL/0050
Status last verified: Jan 2013
First submitted: 2 May 2002
Last updated: 4 Jan 2013
Results posted: No
Data monitoring committee: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma

All Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT00034879
Acronym / sponsor ID: 1839IL/0050
Conditions: Carcinoma, Non-small-cell Lung, Metastases, Neoplasm
Keywords: Locally advanced and/or metastatic non-operable, non-small cell lung cancer (stage III or IV), patients who have failed standard therapy.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2000
Primary completion: Oct 2003 (actual)
Study completion: Oct 2003 (actual)
First posted: 3 May 2002 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZD1839 (Gefitinib)Also: Iressa	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.

Related trials for Carcinoma

Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Iressa Medical Science Director, MD study director

AstraZeneca

626 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZD1839 (Gefitinib) in people with Carcinoma and Non-small-cell Lung, run by AstraZeneca at 626 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 626 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00034879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.