ID

39276

Description

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC); ODM derived from: https://clinicaltrials.gov/show/NCT01822613

Link

https://clinicaltrials.gov/show/NCT01822613

Keywords

  1. 12/16/19 12/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 16, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Esophageal Squamous Cell Carcinoma NCT01822613

Eligibility Esophageal Squamous Cell Carcinoma NCT01822613

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed esophageal squamous cell carcinoma (escc)
Description

Squamous cell carcinoma of esophagus

Data type

boolean

Alias
UMLS CUI [1]
C0279626
no more than one prior chemotherapy regimen for recurrent or metastatic escc (for phase ii only).
Description

Prior Chemotherapy Quantity Oesophageal squamous cell carcinoma recurrent | Prior Chemotherapy Quantity Squamous cell carcinoma of esophagus metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0854769
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0279626
UMLS CUI [2,4]
C1522484
progression during or after platinum-based therapy for recurrent or metastatic escc, or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for localized disease.
Description

Disease Progression | Therapy Platinum-Based Oesophageal squamous cell carcinoma recurrent | Therapy Platinum-Based Squamous cell carcinoma of esophagus metastatic | Disease recurrence | Chemotherapy Platinum-Based | Chemoradiotherapy Local disease

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C0854769
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1514162
UMLS CUI [3,3]
C0279626
UMLS CUI [3,4]
C1522484
UMLS CUI [4]
C0679254
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1514162
UMLS CUI [6,1]
C0436307
UMLS CUI [6,2]
C0277565
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who received prior phosphoinositide-3-kinase (pi3k) inhibitor or anti-receptor tyrosine-protein kinase erbb-3 (erbb3 or her3) antibody treatment, including bi-specific antibodies with her3 as one of the targets (patients with prior exposure to pertuzumab or epidermal growth factor receptor (egfr)-targeted agents are eligible)
Description

PI3K Inhibitor | ERBB3 Receptor Protein-Tyrosine Kinase Antibodies | Bispecific Antibodies HER3 Targeted

Data type

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2,1]
C0072460
UMLS CUI [2,2]
C0003241
UMLS CUI [3,1]
C0206492
UMLS CUI [3,2]
C0812265
UMLS CUI [3,3]
C1521840
patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.
Description

Tumor tissue sample Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0686905
patients with central nervous system (cns) metastatic involvement.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
patients who have received prior systemic anti-cancer treatment, such as cyclical chemotherapy or biological therapy within a period of time that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-c) prior to starting study treatment.
Description

Cancer treatment Systemic | Chemotherapy cycle | Biological treatment | Nitrosourea | Mitomycin

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1302181
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
patients who have received definitive radiotherapy ≤ 4 weeks prior to starting study drug, who have not recovered from side effects of such therapy and/or from whom ≥ 30% of the bone marrow was irradiated.
Description

Therapeutic radiology procedure Recent | Side effects Recovery Lacking | Bone Marrow Percentage irradiated

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C1522449
other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Esophageal Squamous Cell Carcinoma NCT01822613

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus
Item
histologically confirmed esophageal squamous cell carcinoma (escc)
boolean
C0279626 (UMLS CUI [1])
Prior Chemotherapy Quantity Oesophageal squamous cell carcinoma recurrent | Prior Chemotherapy Quantity Squamous cell carcinoma of esophagus metastatic
Item
no more than one prior chemotherapy regimen for recurrent or metastatic escc (for phase ii only).
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0854769 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0279626 (UMLS CUI [2,3])
C1522484 (UMLS CUI [2,4])
Disease Progression | Therapy Platinum-Based Oesophageal squamous cell carcinoma recurrent | Therapy Platinum-Based Squamous cell carcinoma of esophagus metastatic | Disease recurrence | Chemotherapy Platinum-Based | Chemoradiotherapy Local disease
Item
progression during or after platinum-based therapy for recurrent or metastatic escc, or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for localized disease.
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0854769 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C0279626 (UMLS CUI [3,3])
C1522484 (UMLS CUI [3,4])
C0679254 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C1514162 (UMLS CUI [5,2])
C0436307 (UMLS CUI [6,1])
C0277565 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
PI3K Inhibitor | ERBB3 Receptor Protein-Tyrosine Kinase Antibodies | Bispecific Antibodies HER3 Targeted
Item
patients who received prior phosphoinositide-3-kinase (pi3k) inhibitor or anti-receptor tyrosine-protein kinase erbb-3 (erbb3 or her3) antibody treatment, including bi-specific antibodies with her3 as one of the targets (patients with prior exposure to pertuzumab or epidermal growth factor receptor (egfr)-targeted agents are eligible)
boolean
C1519050 (UMLS CUI [1])
C0072460 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
C0206492 (UMLS CUI [3,1])
C0812265 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
Tumor tissue sample Unavailable
Item
patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.
boolean
C0475358 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
CNS metastases
Item
patients with central nervous system (cns) metastatic involvement.
boolean
C0686377 (UMLS CUI [1])
Cancer treatment Systemic | Chemotherapy cycle | Biological treatment | Nitrosourea | Mitomycin
Item
patients who have received prior systemic anti-cancer treatment, such as cyclical chemotherapy or biological therapy within a period of time that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-c) prior to starting study treatment.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1302181 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
Therapeutic radiology procedure Recent | Side effects Recovery Lacking | Bone Marrow Percentage irradiated
Item
patients who have received definitive radiotherapy ≤ 4 weeks prior to starting study drug, who have not recovered from side effects of such therapy and/or from whom ≥ 30% of the bone marrow was irradiated.
boolean
C1522449 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0005953 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial