Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC); ODM derived from:


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December 16, 2019

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Eligibility Esophageal Squamous Cell Carcinoma NCT01822613

Eligibility Esophageal Squamous Cell Carcinoma NCT01822613

Inclusion Criteria
histologically confirmed esophageal squamous cell carcinoma (escc)
no more than one prior chemotherapy regimen for recurrent or metastatic escc (for phase ii only).
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.
Exclusion Criteria
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)
patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.
patients with central nervous system (cns) metastatic involvement.
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.
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.
other protocol-defined inclusion/exclusion criteria may apply.