ID

44316

Description

AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00819169

Link

https://clinicaltrials.gov/show/NCT00819169

Keywords

Versions (2)
  1. 12/28/17 12/28/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00819169

English

Eligibility Colorectal Cancer NCT00819169

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1: histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors
Description

Solid tumour Advanced Locally Unresponsive to Treatment | Solid tumour metastatic Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C0205269
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C0205269
part 2: histologically or cytologically confirmed, locally advanced or metastatic: nsclc (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens), colorectal cancer (up to 2 prior treatment regimens), pancreatic cancer (up to 1 prior treatment regimen), ovarian cancer (up to 2 prior treatment regimens), or sarcoma (up to 2 prior treatment regimens), according to cohort availability
Description

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Therapeutic procedure Quantity Squamous cell carcinoma | Therapeutic procedure Quantity Nonsquamous nonsmall cell neoplasm of lung | Therapeutic procedure Quantity Colorectal Carcinoma | Therapeutic procedure Quantity Pancreatic carcinoma | Therapeutic procedure Quantity Ovarian Carcinoma | Therapeutic procedure Quantity Sarcoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0007137
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C2585890
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1265611
UMLS CUI [5,3]
C0009402
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0235974
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0029925
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C1265611
UMLS CUI [8,3]
C1261473
eastern cooperative group (ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women or men ≥16 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate hematology, renal, hepatic, coagulation and glycemic function.
Description

Hematologic function | Renal function | Liver function | Blood coagulation | Glycemia function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0005778
UMLS CUI [5,1]
C0005802
UMLS CUI [5,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of uncontrolled central nervous system (cns) disease
Description

CNS disorder Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0205318
systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤28 days before enrollment.
Description

Systemic Chemotherapy | Hormone Therapy | Immunotherapy | Monoclonal antibodies, antineoplastic

Data type

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
UMLS CUI [4]
C3542957
prior treatment with death receptor agonists (including but not limited to rhapo2l/trail [amg951], apomab, mapatumumab, lexatumumab, cs-1008)
Description

Death Receptor agonists | AMG 951 | apomab | mapatumumab | lexatumumab | CS-1008

Data type

boolean

Alias
UMLS CUI [1,1]
C1720947
UMLS CUI [1,2]
C0243192
UMLS CUI [2,1]
C2830007
UMLS CUI [2,2]
C2346838
UMLS CUI [3]
C1665688
UMLS CUI [4]
C1721684
UMLS CUI [5]
C1831890
prior treatment with igf receptor antagonists (including but not limited to cp-751, 871, mk0646, ave1642 or imc-a12)
Description

IGF Receptor antagonists | CP 751 | Other Coding | MK 0646 | AVE1642 | IMC-A12

Data type

boolean

Alias
UMLS CUI [1,1]
C0140079
UMLS CUI [1,2]
C0243076
UMLS CUI [2]
C1707143
UMLS CUI [3]
C3846158
UMLS CUI [4]
C1831888
UMLS CUI [5]
C2703165
UMLS CUI [6]
C3180625
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Similar models

Eligibility Colorectal Cancer NCT00819169

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Solid tumour Advanced Locally Unresponsive to Treatment | Solid tumour metastatic Unresponsive to Treatment
Item
part 1: histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0205269 (UMLS CUI [1,4])
C0280100 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Therapeutic procedure Quantity Squamous cell carcinoma | Therapeutic procedure Quantity Nonsquamous nonsmall cell neoplasm of lung | Therapeutic procedure Quantity Colorectal Carcinoma | Therapeutic procedure Quantity Pancreatic carcinoma | Therapeutic procedure Quantity Ovarian Carcinoma | Therapeutic procedure Quantity Sarcoma
Item
part 2: histologically or cytologically confirmed, locally advanced or metastatic: nsclc (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens), colorectal cancer (up to 2 prior treatment regimens), pancreatic cancer (up to 1 prior treatment regimen), ovarian cancer (up to 2 prior treatment regimens), or sarcoma (up to 2 prior treatment regimens), according to cohort availability
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0007137 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C2585890 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0009402 (UMLS CUI [5,3])
C0087111 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0235974 (UMLS CUI [6,3])
C0087111 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0029925 (UMLS CUI [7,3])
C0087111 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C1261473 (UMLS CUI [8,3])
ECOG performance status
Item
eastern cooperative group (ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
women or men ≥16 years of age
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Blood coagulation | Glycemia function
Item
adequate hematology, renal, hepatic, coagulation and glycemic function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0005778 (UMLS CUI [4])
C0005802 (UMLS CUI [5,1])
C0031843 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
CNS disorder Uncontrolled
Item
presence of uncontrolled central nervous system (cns) disease
boolean
C0007682 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Systemic Chemotherapy | Hormone Therapy | Immunotherapy | Monoclonal antibodies, antineoplastic
Item
systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤28 days before enrollment.
boolean
C1883256 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C3542957 (UMLS CUI [4])
Death Receptor agonists | AMG 951 | apomab | mapatumumab | lexatumumab | CS-1008
Item
prior treatment with death receptor agonists (including but not limited to rhapo2l/trail [amg951], apomab, mapatumumab, lexatumumab, cs-1008)
boolean
C1720947 (UMLS CUI [1,1])
C0243192 (UMLS CUI [1,2])
C2830007 (UMLS CUI [2,1])
C2346838 (UMLS CUI [2,2])
C1665688 (UMLS CUI [3])
C1721684 (UMLS CUI [4])
C1831890 (UMLS CUI [5])
IGF Receptor antagonists | CP 751 | Other Coding | MK 0646 | AVE1642 | IMC-A12
Item
prior treatment with igf receptor antagonists (including but not limited to cp-751, 871, mk0646, ave1642 or imc-a12)
boolean
C0140079 (UMLS CUI [1,1])
C0243076 (UMLS CUI [1,2])
C1707143 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C1831888 (UMLS CUI [4])
C2703165 (UMLS CUI [5])
C3180625 (UMLS CUI [6])
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