ID

35465

Beskrivning

Phase 1 Study of MGD007 in Relapsed/Refractory Metastatic Colorectal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02248805

Länk

https://clinicaltrials.gov/show/NCT02248805

Nyckelord

Versioner (1)
  1. 2019-03-05 2019-03-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 mars 2019

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Carcinoma NCT02248805

Engelsk

Eligibility Colorectal Carcinoma NCT02248805

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
for the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined.
Beskrivning

Dose Escalation Cohort | Adenocarcinoma of large intestine metastatic | Unresponsive to Standard therapy Quantity | Standard therapy Rejected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3816728
UMLS CUI [1,2]
C0599755
UMLS CUI [2,1]
C1319315
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C2936643
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C1548437
for the dose expansion cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 1 prior standard treatment regimen or standard therapy was declined.
Beskrivning

Dose Expansion Cohort | Adenocarcinoma of large intestine metastatic | Unresponsive to Standard therapy Quantity | Standard therapy Rejected

Datatyp

boolean

Alias
UMLS CUI [1]
C4521283
UMLS CUI [2,1]
C1319315
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C2936643
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C1548437
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
measurable disease
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
intolerance to at least 2 prior standard therapy regimens
Beskrivning

Intolerance Standard therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C1265611
acceptable laboratory parameters
Beskrivning

Laboratory Results Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1879533
adult (≥18 years old)
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known brain metastasis
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior grave's disease)
Beskrivning

Autoimmune Diseases | Autoimmune Diseases Suspected | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception Graves Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0042900
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1276071
UMLS CUI [4,3]
C1514893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0018213
prior history of allogeneic bone marrow, stem-cell, or solid organ transplantation
Beskrivning

Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Solid organ transplant Allogeneic

Datatyp

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C2242529
UMLS CUI [3,1]
C0730400
UMLS CUI [3,2]
C1515895
prior treatment with checkpoint inhibitors and other immunotherapy treatments, including anti-lag-3, anti-pd-1, anti-pd-l1 or anti-ctla-4 antibodies, if less than 5 half lives before study drug administration
Beskrivning

Other Coding | Immunotherapy | Anti-LAG-3 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody

Datatyp

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0021083
UMLS CUI [3]
C4525145
UMLS CUI [4]
C4289970
UMLS CUI [5]
C4289971
UMLS CUI [6]
C4289973
prior history of grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors or other immunotherapy treatments.
Beskrivning

Diarrhea due to drug Grade | Drug-induced colitis Grade | Other Coding | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1996989
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0341336
UMLS CUI [2,2]
C0441800
UMLS CUI [3]
C3846158
UMLS CUI [4]
C0021083
treatment with any local or systemic anti-neoplastic therapy or any other investigational agent in the 4 weeks prior to study drug administration
Beskrivning

Cancer treatment Local | Cancer treatment Systemic | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0013230
require, at the time of study entry, treatment with steroids > 10 mg/day of oral prednisone (or equivalent), except topical use, steroid inhaler, nasal spray or ophthalmic solution
Beskrivning

Steroids | Prednisone Oral Product U/day | Equivalent | Exception Topical steroids | Exception Inhaled steroids use | Exception Steroids Nasal Spray | Exception Steroids Ophthalmic Solution

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C3216040
UMLS CUI [2,2]
C0456683
UMLS CUI [3]
C0205163
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2064827
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0586793
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0038317
UMLS CUI [6,3]
C0461725
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0038317
UMLS CUI [7,3]
C0029083
history of clinically significant cardiovascular disease, gastrointestinal disorder, or significant pulmonary compromise.
Beskrivning

Cardiovascular Disease | Gastrointestinal Diseases | Pulmonary function impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0858943
second primary malignancy that has not been in remission for greater than 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ,or squamous intraepithelial lesion on pap smear, localized prostate cancer (gleason score <6), or resected melanoma in situ.
Beskrivning

Second Primary Cancer | Remission Absent | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Squamous intraepithelial lesion Pap smear | Exception Prostate carcinoma Localized Gleason score | Exception Melanoma in situ Resected

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C0687702
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0333873
UMLS CUI [5,3]
C0079104
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C0392752
UMLS CUI [6,4]
C3203027
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0854696
UMLS CUI [7,3]
C1521996
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Similar models

Eligibility Colorectal Carcinoma NCT02248805

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Dose Escalation Cohort | Adenocarcinoma of large intestine metastatic | Unresponsive to Standard therapy Quantity | Standard therapy Rejected
Item
for the dose escalation cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 2 prior standard treatment regimens or standard treatment was declined.
boolean
C3816728 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C1319315 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C1548437 (UMLS CUI [4,2])
Dose Expansion Cohort | Adenocarcinoma of large intestine metastatic | Unresponsive to Standard therapy Quantity | Standard therapy Rejected
Item
for the dose expansion cohorts, histologically-proven metastatic colorectal adenocarcinoma that is refractory to 1 prior standard treatment regimen or standard therapy was declined.
boolean
C4521283 (UMLS CUI [1])
C1319315 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C1548437 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Intolerance Standard therapy Quantity
Item
intolerance to at least 2 prior standard therapy regimens
boolean
C0231199 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Laboratory Results Acceptable
Item
acceptable laboratory parameters
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Adult | Age
Item
adult (≥18 years old)
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
known brain metastasis
boolean
C0220650 (UMLS CUI [1])
Autoimmune Diseases | Autoimmune Diseases Suspected | Exception Vitiligo | Exception Childhood atopic dermatitis resolved | Exception Graves Disease
Item
any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior grave's disease)
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0042900 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1276071 (UMLS CUI [4,2])
C1514893 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0018213 (UMLS CUI [5,2])
Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Solid organ transplant Allogeneic
Item
prior history of allogeneic bone marrow, stem-cell, or solid organ transplantation
boolean
C0149615 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
C0730400 (UMLS CUI [3,1])
C1515895 (UMLS CUI [3,2])
Other Coding | Immunotherapy | Anti-LAG-3 Monoclonal Antibody | Anti-PD1 Monoclonal Antibody | Anti-PD-L1 Monoclonal Antibody | Anti-CTLA-4 Monoclonal Antibody
Item
prior treatment with checkpoint inhibitors and other immunotherapy treatments, including anti-lag-3, anti-pd-1, anti-pd-l1 or anti-ctla-4 antibodies, if less than 5 half lives before study drug administration
boolean
C3846158 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C4525145 (UMLS CUI [3])
C4289970 (UMLS CUI [4])
C4289971 (UMLS CUI [5])
C4289973 (UMLS CUI [6])
Diarrhea due to drug Grade | Drug-induced colitis Grade | Other Coding | Immunotherapy
Item
prior history of grade 3 or greater drug-related diarrhea/colitis during treatment with checkpoint inhibitors or other immunotherapy treatments.
boolean
C1996989 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0341336 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
Cancer treatment Local | Cancer treatment Systemic | Investigational New Drugs
Item
treatment with any local or systemic anti-neoplastic therapy or any other investigational agent in the 4 weeks prior to study drug administration
boolean
C0920425 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
Steroids | Prednisone Oral Product U/day | Equivalent | Exception Topical steroids | Exception Inhaled steroids use | Exception Steroids Nasal Spray | Exception Steroids Ophthalmic Solution
Item
require, at the time of study entry, treatment with steroids > 10 mg/day of oral prednisone (or equivalent), except topical use, steroid inhaler, nasal spray or ophthalmic solution
boolean
C0038317 (UMLS CUI [1])
C3216040 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0586793 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0038317 (UMLS CUI [6,2])
C0461725 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0038317 (UMLS CUI [7,2])
C0029083 (UMLS CUI [7,3])
Cardiovascular Disease | Gastrointestinal Diseases | Pulmonary function impairment
Item
history of clinically significant cardiovascular disease, gastrointestinal disorder, or significant pulmonary compromise.
boolean
C0007222 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0858943 (UMLS CUI [3])
Second Primary Cancer | Remission Absent | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Squamous intraepithelial lesion Pap smear | Exception Prostate carcinoma Localized Gleason score | Exception Melanoma in situ Resected
Item
second primary malignancy that has not been in remission for greater than 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ,or squamous intraepithelial lesion on pap smear, localized prostate cancer (gleason score <6), or resected melanoma in situ.
boolean
C0751623 (UMLS CUI [1])
C0687702 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0333873 (UMLS CUI [5,2])
C0079104 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C0392752 (UMLS CUI [6,3])
C3203027 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0854696 (UMLS CUI [7,2])
C1521996 (UMLS CUI [7,3])
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