ID

39261

Beschreibung

A Study of the Safety and Pharmacokinetics of MEHD7945A in Patients With Locally Advanced or Metastatic Epithelial Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT01207323

Link

https://clinicaltrials.gov/show/NCT01207323

Stichworte

Versionen (1)
  1. 13.12.19 13.12.19 -
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See clinicaltrials.gov

Hochgeladen am

13. Dezember 2019

DOI

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Creative Commons BY 4.0
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Eligibility Epithelial Tumors, Malignant NCT01207323

Englisch

Eligibility Epithelial Tumors, Malignant NCT01207323

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
life expectancy >/= 12 weeks
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
availability and willingness to provide sufficient tumor tissue sample for testing
Beschreibung

Availability of Tumor tissue sample | Testing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2]
C0039593
dose-escalation stage: patients with histologically documented incurable, locally advanced, or metastatic epithelial malignancy that has progressed despite standard therapy or for which no standard therapy exists
Beschreibung

Carcinoma incurable | Carcinoma Advanced Locally | Metastatic Carcinoma | Disease Progression | Standard therapy | Standard therapy Unavailable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0175969
UMLS CUI [2,1]
C0007097
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3]
C1384494
UMLS CUI [4]
C0242656
UMLS CUI [5]
C2936643
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C0686905
expansion stage: patients with one of the following epithelial, histologically-documented, incurable, locally advanced, or metastatic tumor that has progressed despite standard therapy or for which no standard therapy exists: colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, or pancreatic cancer
Beschreibung

Carcinoma incurable | Carcinoma Advanced Locally | Metastatic Carcinoma | Disease Progression | Standard therapy | Standard therapy Unavailable | Colorectal Carcinoma | Non-Small Cell Lung Carcinoma | Squamous cell carcinoma of the head and neck | Pancreatic carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C0175969
UMLS CUI [2,1]
C0007097
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3]
C1384494
UMLS CUI [4]
C0242656
UMLS CUI [5]
C2936643
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C0686905
UMLS CUI [7]
C0009402
UMLS CUI [8]
C0007131
UMLS CUI [9]
C1168401
UMLS CUI [10]
C0235974
use of an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for men and women of childbearing potential while enrolled in the study
Beschreibung

Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Sexual Abstinence | Hormonal contraception | Barrier Contraception Double | Sexual sterilization Partner in relationship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0036899
UMLS CUI [4]
C2985296
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6,1]
C0038288
UMLS CUI [6,2]
C0682323
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
< 4 weeks since the last anti-tumor therapy prior to day 1 of study treatment
Beschreibung

Cancer treatment Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332185
major surgical procedure within 4 weeks prior to day 1 of study treatment
Beschreibung

Major surgery Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
leptomeningeal disease as the only manifestation of the current malignancy
Beschreibung

Leptomeningeal Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0751297
active infection requiring iv antibiotics
Beschreibung

Communicable Disease Requirement Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003232
active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
Beschreibung

Autoimmune Disease Uncontrolled | NSAIDs Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0332268
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Beschreibung

Hypercalcemia Symptomatic | Requirement Bisphosphonate therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C4510264
current severe, uncontrolled systemic disease
Beschreibung

Systemic disease Severe Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
history of cardiac heart failure of any new york heart association criteria or serious cardiac arrhythmia requiring treatment
Beschreibung

Heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332121
history of myocardial infarction within 6 months before day 1, or history of unstable angina
Beschreibung

Myocardial Infarction | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Beschreibung

Liver diseases | Viral hepatitis | Hepatitis | Alcohol abuse | Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0085762
UMLS CUI [5]
C0023890
history of interstitial lung disease
Beschreibung

Lung Diseases, Interstitial

Datentyp

boolean

Alias
UMLS CUI [1]
C0206062
history of severe allergic or hypersensitivity reaction to other therapeutic antibodies that required discontinuation of therapy
Beschreibung

Severe allergic reaction Antibodies Therapeutic | Severe allergy Antibodies Therapeutic | Therapy Discontinuation Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2220378
UMLS CUI [1,2]
C0003241
UMLS CUI [1,3]
C0302350
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0003241
UMLS CUI [2,3]
C0302350
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1514873
known human immunodeficiency virus (hiv) infection
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
primary central nervous system (cns) malignancy or untreated/active cns metastases
Beschreibung

Central Nervous System Neoplasms, Primary | CNS metastases untreated | CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0751620
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0686377
significant traumatic injury within 4 weeks prior to day 1 of study treatment
Beschreibung

Traumatic injury

Datentyp

boolean

Alias
UMLS CUI [1]
C3263723
pregnancy or lactation
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

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

Eligibility Epithelial Tumors, Malignant NCT01207323

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Life Expectancy
Item
life expectancy >/= 12 weeks
boolean
C0023671 (UMLS CUI [1])
Availability of Tumor tissue sample | Testing
Item
availability and willingness to provide sufficient tumor tissue sample for testing
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0039593 (UMLS CUI [2])
Carcinoma incurable | Carcinoma Advanced Locally | Metastatic Carcinoma | Disease Progression | Standard therapy | Standard therapy Unavailable
Item
dose-escalation stage: patients with histologically documented incurable, locally advanced, or metastatic epithelial malignancy that has progressed despite standard therapy or for which no standard therapy exists
boolean
C0007097 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0007097 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C1384494 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C2936643 (UMLS CUI [5])
C2936643 (UMLS CUI [6,1])
C0686905 (UMLS CUI [6,2])
Carcinoma incurable | Carcinoma Advanced Locally | Metastatic Carcinoma | Disease Progression | Standard therapy | Standard therapy Unavailable | Colorectal Carcinoma | Non-Small Cell Lung Carcinoma | Squamous cell carcinoma of the head and neck | Pancreatic carcinoma
Item
expansion stage: patients with one of the following epithelial, histologically-documented, incurable, locally advanced, or metastatic tumor that has progressed despite standard therapy or for which no standard therapy exists: colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, or pancreatic cancer
boolean
C0007097 (UMLS CUI [1,1])
C0175969 (UMLS CUI [1,2])
C0007097 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C1384494 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C2936643 (UMLS CUI [5])
C2936643 (UMLS CUI [6,1])
C0686905 (UMLS CUI [6,2])
C0009402 (UMLS CUI [7])
C0007131 (UMLS CUI [8])
C1168401 (UMLS CUI [9])
C0235974 (UMLS CUI [10])
Gender Contraceptive methods | Childbearing Potential Contraceptive methods | Sexual Abstinence | Hormonal contraception | Barrier Contraception Double | Sexual sterilization Partner in relationship
Item
use of an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for men and women of childbearing potential while enrolled in the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C2985296 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0038288 (UMLS CUI [6,1])
C0682323 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Recent
Item
< 4 weeks since the last anti-tumor therapy prior to day 1 of study treatment
boolean
C0920425 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Major surgery Recent
Item
major surgical procedure within 4 weeks prior to day 1 of study treatment
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Leptomeningeal Neoplasm
Item
leptomeningeal disease as the only manifestation of the current malignancy
boolean
C0751297 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics
Item
active infection requiring iv antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Autoimmune Disease Uncontrolled | NSAIDs Lacking
Item
active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
boolean
C0004364 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Hypercalcemia Symptomatic | Requirement Bisphosphonate therapy
Item
symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C4510264 (UMLS CUI [2,2])
Systemic disease Severe Uncontrolled
Item
current severe, uncontrolled systemic disease
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Treatment required for
Item
history of cardiac heart failure of any new york heart association criteria or serious cardiac arrhythmia requiring treatment
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332121 (UMLS CUI [2,3])
Myocardial Infarction | Angina, Unstable
Item
history of myocardial infarction within 6 months before day 1, or history of unstable angina
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Liver diseases | Viral hepatitis | Hepatitis | Alcohol abuse | Liver Cirrhosis
Item
clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
boolean
C0023895 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0085762 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
Lung Diseases, Interstitial
Item
history of interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Severe allergic reaction Antibodies Therapeutic | Severe allergy Antibodies Therapeutic | Therapy Discontinuation Required
Item
history of severe allergic or hypersensitivity reaction to other therapeutic antibodies that required discontinuation of therapy
boolean
C2220378 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C2945656 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0302350 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Neoplasms, Primary | CNS metastases untreated | CNS metastases
Item
primary central nervous system (cns) malignancy or untreated/active cns metastases
boolean
C0751620 (UMLS CUI [1])
C0686377 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3])
Traumatic injury
Item
significant traumatic injury within 4 weeks prior to day 1 of study treatment
boolean
C3263723 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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