ID

16800

Beschreibung

Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00078468

Link

https://clinicaltrials.gov/show/NCT00078468

Stichworte

Versionen (1)
  1. 08.08.16 08.08.16 -
Hochgeladen am

8. August 2016

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00078468

Englisch

Eligibility Colorectal Neoplasms NCT00078468

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
Beschreibung

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
stage iv or recurrent disease
Beschreibung

TNM clinical staging | Recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0277556
measurable disease
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-fu/lv)
Beschreibung

Disease Progression | Disease recurrence | fluorouracil/leucovorin calcium | Chemotherapy First line treatment Complete

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0679254
UMLS CUI [3]
C0278707
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C1708063
UMLS CUI [4,3]
C0205197
prior irinotecan or oxaliplatin as part of the 5-fu/lv regimen or as subsequent therapy allowed
Beschreibung

irinotecan | oxaliplatin | fluorouracil/leucovorin calcium

Datentyp

boolean

Alias
UMLS CUI [1]
C0123931
UMLS CUI [2]
C0069717
UMLS CUI [3]
C0278707
only 2 prior regimens for metastatic disease allowed
Beschreibung

Prior Therapy Quantity Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
one additional regimen as adjuvant therapy allowed provided patient remained disease-free for > 6 months after completion of therapy*
Beschreibung

Adjuvant therapy Quantity | Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not
Beschreibung

Investigational New Drugs Targeted | cetuximab | bevacizumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1521840
UMLS CUI [2]
C0995188
UMLS CUI [3]
C0796392
counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen note: *if evidence of failure occurred within < 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease
Beschreibung

Chemotherapy | Combined Modality Therapy | Cytotoxic agent | Adjuvant therapy Complete failed | Additional Therapy Quantity Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0304497
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0231175
UMLS CUI [5,1]
C1706712
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0027627
no active brain metastases (requiring treatment or progressing)
Beschreibung

Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0242656
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of blood transfusion within 14 days
Beschreibung

Blood Transfusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0005841
need of concurrent administration of allopurinol
Beschreibung

Allopurinol Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002144
UMLS CUI [1,2]
C0686904
history of radiotherapy or chemotherapy within 4 weeks
Beschreibung

Therapeutic radiology procedure | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol
Beschreibung

Condition Exclusion Protocol Compliance | Addictive Behavior Exclusion Protocol Compliance | Family problems Exclusion Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0424960
UMLS CUI [3,2]
C2828389
UMLS CUI [3,3]
C0525058
any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives
Beschreibung

medical condition Unstable Interferes with Protocol Compliance | medical condition Severe Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
receipt of an investigational agent within 28 days prior to first day of dosing with ag-2037
Beschreibung

Investigational New Drugs | AG2037

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0935874
pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous treatment with garft inhibitors
Beschreibung

Glycinamide Ribonucleotide Formyltransferase Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C1512220
history of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
Beschreibung

Malignant Neoplasms | Colorectal Carcinoma | curative treatment Skin carcinoma | curative treatment Stage 0 Breast Carcinoma | curative treatment Cervix carcinoma | curative treatment Malignant Neoplasms | Disease Evidence

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0009402
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C0154084
UMLS CUI [5,1]
C1273390
UMLS CUI [5,2]
C0302592
UMLS CUI [6,1]
C1273390
UMLS CUI [6,2]
C0006826
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C3887511
active brain metastases (requiring treatment or progression)
Beschreibung

Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2]
C0242656
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Ähnliche Modelle

Eligibility Colorectal Neoplasms NCT00078468

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
TNM clinical staging | Recurrent disease
Item
stage iv or recurrent disease
boolean
C3258246 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Disease Progression | Disease recurrence | fluorouracil/leucovorin calcium | Chemotherapy First line treatment Complete
Item
disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-fu/lv)
boolean
C0242656 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0278707 (UMLS CUI [3])
C0392920 (UMLS CUI [4,1])
C1708063 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
irinotecan | oxaliplatin | fluorouracil/leucovorin calcium
Item
prior irinotecan or oxaliplatin as part of the 5-fu/lv regimen or as subsequent therapy allowed
boolean
C0123931 (UMLS CUI [1])
C0069717 (UMLS CUI [2])
C0278707 (UMLS CUI [3])
Prior Therapy Quantity Neoplasm Metastasis
Item
only 2 prior regimens for metastatic disease allowed
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Adjuvant therapy Quantity | Disease Free of
Item
one additional regimen as adjuvant therapy allowed provided patient remained disease-free for > 6 months after completion of therapy*
boolean
C0677850 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Investigational New Drugs Targeted | cetuximab | bevacizumab
Item
newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not
boolean
C0013230 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0995188 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
Chemotherapy | Combined Modality Therapy | Cytotoxic agent | Adjuvant therapy Complete failed | Additional Therapy Quantity Neoplasm Metastasis
Item
counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen note: *if evidence of failure occurred within < 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease
boolean
C0392920 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0304497 (UMLS CUI [3])
C0677850 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
C1706712 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0027627 (UMLS CUI [5,3])
Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression
Item
no active brain metastases (requiring treatment or progressing)
boolean
C0220650 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Blood Transfusion
Item
history of blood transfusion within 14 days
boolean
C0005841 (UMLS CUI [1])
Allopurinol Patient need for
Item
need of concurrent administration of allopurinol
boolean
C0002144 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Therapeutic radiology procedure | Chemotherapy
Item
history of radiotherapy or chemotherapy within 4 weeks
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Condition Exclusion Protocol Compliance | Addictive Behavior Exclusion Protocol Compliance | Family problems Exclusion Protocol Compliance
Item
any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol
boolean
C0348080 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0424960 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
medical condition Unstable Interferes with Protocol Compliance | medical condition Severe Interferes with Protocol Compliance
Item
any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Investigational New Drugs | AG2037
Item
receipt of an investigational agent within 28 days prior to first day of dosing with ag-2037
boolean
C0013230 (UMLS CUI [1])
C0935874 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Glycinamide Ribonucleotide Formyltransferase Inhibitor
Item
previous treatment with garft inhibitors
boolean
C1512220 (UMLS CUI [1])
Malignant Neoplasms | Colorectal Carcinoma | curative treatment Skin carcinoma | curative treatment Stage 0 Breast Carcinoma | curative treatment Cervix carcinoma | curative treatment Malignant Neoplasms | Disease Evidence
Item
history of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
boolean
C0006826 (UMLS CUI [1])
C0009402 (UMLS CUI [2])
C1273390 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1273390 (UMLS CUI [4,1])
C0154084 (UMLS CUI [4,2])
C1273390 (UMLS CUI [5,1])
C0302592 (UMLS CUI [5,2])
C1273390 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0012634 (UMLS CUI [7,1])
C3887511 (UMLS CUI [7,2])
Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression
Item
active brain metastases (requiring treatment or progression)
boolean
C0220650 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
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