Eligibility Esophageal Squamous Cell Carcinoma NCT01822613

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

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])