ID

12984

Description

Iressa Expanded Access Program (EAP); ODM derived from: https://clinicaltrials.gov/show/NCT00034879

Link

https://clinicaltrials.gov/show/NCT00034879

Keywords

  1. 1/9/16 1/9/16 -
Uploaded on

January 9, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Carcinoma NCT00034879

Eligibility Carcinoma NCT00034879

  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00034879
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous documented histologically or cytologically confirmed non-small cell lung cancer;
Description

non-small cell lung cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0019638
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0010819
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.
Description

tumor stage, chemo-/radiotherapy, study participation, comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C1300072
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C2348568
UMLS CUI [5]
C0009488
age 18 years or older;
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent to participate in the trial.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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;
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
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;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
having other active malignancies;
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
incomplete healing from previous oncologic or other major surgery;
Description

surgery

Data type

boolean

Alias
UMLS CUI [1]
C0038894
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pregnancy or breast feeding (women of child-bearing potential).
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Carcinoma NCT00034879

  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00034879
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
non-small cell lung cancer
Item
previous documented histologically or cytologically confirmed non-small cell lung cancer;
boolean
C0007131 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0010819 (UMLS CUI [2,2])
tumor stage, chemo-/radiotherapy, study participation, comorbidity
Item
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.
boolean
C1300072 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
age
Item
age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
written informed consent to participate in the trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
therapy
Item
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;
boolean
C0087111 (UMLS CUI [1])
Study Subject Participation Status
Item
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;
boolean
C2348568 (UMLS CUI [1])
malignancies
Item
having other active malignancies;
boolean
C0006826 (UMLS CUI [1])
surgery
Item
incomplete healing from previous oncologic or other major surgery;
boolean
C0038894 (UMLS CUI [1])
comorbidity
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
boolean
C0009488 (UMLS CUI [1])
pregnancy, breast feeding
Item
pregnancy or breast feeding (women of child-bearing potential).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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