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

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Trial Conditions
  • Carcinoma
  • Non-Small-Cell Lung
  • Metastases
  • Neoplasm
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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).

Gender: Both
Steward Physician(s)
  • Iressa Medical Science Director, MD
Trial Interventions
Drug
  • ZD1839 (Gefitinib)
Physician Researcher

Investigator Name:

  • Iressa Medical Science Director, MD

Other Information

Sponsor: AstraZeneca
Phase: Phase 3
Trial ID: NCT00034879
Volunteers:  Not Accepting Healthy Volunteers

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