ID

36388

Descrizione

Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02069704

collegamento

https://clinicaltrials.gov/show/NCT02069704

Keywords

versioni (1)
  1. 09/05/19 09/05/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

9 maggio 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer. NCT02069704

Inglese

Eligibility Metastatic Colorectal Cancer. NCT02069704

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient must not have had prior chemotherapy for advanced or metastatic disease. patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
Descrizione

Prior Chemotherapy Absent Advanced disease | Prior Chemotherapy Absent Neoplasm Metastasis | Chemotherapy, Adjuvant | Chemoradiotherapy, Adjuvant

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0027627
UMLS CUI [3]
C0085533
UMLS CUI [4]
C3178761
2. patient with mcrc for whom bio-chemotherapy is indicated.
Descrizione

Colorectal cancer metastatic | Indication Chemotherapy Combined Biological treatment

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0205195
UMLS CUI [2,4]
C1531518
3. patients must have at least one measurable non-irradiated site of disease according to recist (version 1.1) criteria. if the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation.
Descrizione

Measurable Disease Site Quantity | Therapeutic radiology procedure Absent Measurable Disease | Prior radiation therapy Lesion | Disease Progression

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1513041
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0221198
UMLS CUI [4]
C0242656
4. minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
Descrizione

Major surgery | Therapeutic radiology procedure Completed | Cancer treatment Systemic Completed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0205197
5. ecog performance status ≤ 2.
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate bone marrow function
Descrizione

Bone Marrow function

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
7. adequate liver function defined within specific parameters
Descrizione

Liver function | Parameters Specific

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2,1]
C0449381
UMLS CUI [2,2]
C0205369
8. adequate renal function defined within specific parameters
Descrizione

Renal function | Parameters Specific

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2,1]
C0449381
UMLS CUI [2,2]
C0205369
9. adequate coagulation parameters defined within specific parameters
Descrizione

Coagulation Parameters | Parameters Specific

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005778
UMLS CUI [1,2]
C0449381
UMLS CUI [2,1]
C0449381
UMLS CUI [2,2]
C0205369
10. negative pregnancy test for females of a childbearing potential.
Descrizione

Childbearing Potential Pregnancy test negative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
11. use of an effective form of contraception during the study (for subjects of childbearing potential and their partners).
Descrizione

Childbearing Potential Contraceptive methods | Partner in relationship Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
12. life expectation ≥ 3 months
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment for advanced or metastatic colorectal cancer.
Descrizione

Prior Therapy Colorectal Carcinoma Advanced | Prior Therapy Colorectal cancer metastatic

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0009402
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0948380
2. prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
Descrizione

Angiogenesis Inhibitors Neoadjuvant Therapy | Angiogenesis Inhibitors Adjuvant therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0596087
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0596087
UMLS CUI [2,2]
C0677850
3. concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
Descrizione

Antineoplastic Agents Investigational

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1517586
4. history of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
Descrizione

Cancer Other | Exception In complete remission | Exception Cancer treatment Completed

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677874
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0920425
UMLS CUI [3,3]
C0205197
5. chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
Descrizione

Systemic steroids chronic | Immunosuppressive Agents chronic | Topical form corticosteroids allowed | Adrenal Cortex Hormones Inhaled allowed

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0304604
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0001559
UMLS CUI [4,3]
C0683607
6. scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
Descrizione

Immunization Attenuated Vaccines Scheduled

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020971
UMLS CUI [1,2]
C0042211
UMLS CUI [1,3]
C0205539
7. uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
Descrizione

Metastatic malignant neoplasm to brain Uncontrolled | Metastatic Malignant Neoplasm to the Leptomeninges Uncontrolled | Glucocorticoids Required Metastatic malignant neoplasm to brain | Glucocorticoids Required Metastatic Malignant Neoplasm to the Leptomeninges

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0220650
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C1704231
8. patients with active bleeding or history of bleeding diathesis on oral anti-vitamin k medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
Descrizione

Hemorrhage | Bleeding tendency | Vitamin K antagonists | Exception Coumadin Low dose | Blood Coagulation Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C1458140
UMLS CUI [3]
C3653316
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699129
UMLS CUI [4,3]
C0445550
UMLS CUI [5]
C0005779
9. patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
Descrizione

Cerebrovascular accident | Transient Ischemic Attack | Subarachnoid Hemorrhage

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0038525
10. patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Descrizione

Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2348568
11. patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization
Descrizione

Non-healed wound Serious | Ulcer | Bone fracture | Major surgery | Traumatic injury

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
UMLS CUI [4]
C0679637
UMLS CUI [5]
C3263723
12. patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition.
Descrizione

Sign or Symptom Gastrointestinal obstruction | Requirement Hydration Therapy Parenteral | Requirement Parenteral Nutrition | Requirement Parenteral nutrition and hydration

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0236124
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1881074
UMLS CUI [2,3]
C1518896
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0030547
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C2223918
13. patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization.
Descrizione

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
14. patients with history of hypersensitivity to any of the study drugs or ingredients.
Descrizione

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Ingredient

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
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Similar models

Eligibility Metastatic Colorectal Cancer. NCT02069704

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Prior Chemotherapy Absent Advanced disease | Prior Chemotherapy Absent Neoplasm Metastasis | Chemotherapy, Adjuvant | Chemoradiotherapy, Adjuvant
Item
1. patient must not have had prior chemotherapy for advanced or metastatic disease. patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3])
C3178761 (UMLS CUI [4])
Colorectal cancer metastatic | Indication Chemotherapy Combined Biological treatment
Item
2. patient with mcrc for whom bio-chemotherapy is indicated.
boolean
C0948380 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C1531518 (UMLS CUI [2,4])
Measurable Disease Site Quantity | Therapeutic radiology procedure Absent Measurable Disease | Prior radiation therapy Lesion | Disease Progression
Item
3. patients must have at least one measurable non-irradiated site of disease according to recist (version 1.1) criteria. if the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation.
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
Major surgery | Therapeutic radiology procedure Completed | Cancer treatment Systemic Completed
Item
4. minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
ECOG performance status
Item
5. ecog performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function
Item
6. adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Liver function | Parameters Specific
Item
7. adequate liver function defined within specific parameters
boolean
C0232741 (UMLS CUI [1])
C0449381 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Renal function | Parameters Specific
Item
8. adequate renal function defined within specific parameters
boolean
C0232804 (UMLS CUI [1])
C0449381 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Coagulation Parameters | Parameters Specific
Item
9. adequate coagulation parameters defined within specific parameters
boolean
C0005778 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0449381 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative
Item
10. negative pregnancy test for females of a childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Partner in relationship Contraceptive methods
Item
11. use of an effective form of contraception during the study (for subjects of childbearing potential and their partners).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Life Expectancy
Item
12. life expectation ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Colorectal Carcinoma Advanced | Prior Therapy Colorectal cancer metastatic
Item
1. prior treatment for advanced or metastatic colorectal cancer.
boolean
C1514463 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0948380 (UMLS CUI [2,2])
Angiogenesis Inhibitors Neoadjuvant Therapy | Angiogenesis Inhibitors Adjuvant therapy
Item
2. prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
boolean
C0596087 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0596087 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
Antineoplastic Agents Investigational
Item
3. concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Cancer Other | Exception In complete remission | Exception Cancer treatment Completed
Item
4. history of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0920425 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Systemic steroids chronic | Immunosuppressive Agents chronic | Topical form corticosteroids allowed | Adrenal Cortex Hormones Inhaled allowed
Item
5. chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
boolean
C2825233 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0304604 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0001559 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Immunization Attenuated Vaccines Scheduled
Item
6. scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
boolean
C0020971 (UMLS CUI [1,1])
C0042211 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Uncontrolled | Metastatic Malignant Neoplasm to the Leptomeninges Uncontrolled | Glucocorticoids Required Metastatic malignant neoplasm to brain | Glucocorticoids Required Metastatic Malignant Neoplasm to the Leptomeninges
Item
7. uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0220650 (UMLS CUI [3,3])
C0017710 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C1704231 (UMLS CUI [4,3])
Hemorrhage | Bleeding tendency | Vitamin K antagonists | Exception Coumadin Low dose | Blood Coagulation Disorders
Item
8. patients with active bleeding or history of bleeding diathesis on oral anti-vitamin k medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
boolean
C0019080 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C3653316 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0699129 (UMLS CUI [4,2])
C0445550 (UMLS CUI [4,3])
C0005779 (UMLS CUI [5])
Cerebrovascular accident | Transient Ischemic Attack | Subarachnoid Hemorrhage
Item
9. patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0038525 (UMLS CUI [3])
Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status
Item
10. patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Non-healed wound Serious | Ulcer | Bone fracture | Major surgery | Traumatic injury
Item
11. patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
C0679637 (UMLS CUI [4])
C3263723 (UMLS CUI [5])
Sign or Symptom Gastrointestinal obstruction | Requirement Hydration Therapy Parenteral | Requirement Parenteral Nutrition | Requirement Parenteral nutrition and hydration
Item
12. patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition.
boolean
C3540840 (UMLS CUI [1,1])
C0236124 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1881074 (UMLS CUI [2,2])
C1518896 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0030547 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C2223918 (UMLS CUI [4,2])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
13. patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization.
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Ingredient
Item
14. patients with history of hypersensitivity to any of the study drugs or ingredients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
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