A phase Ib/II, open-label study of LJM716 in combination with BYL719 compared to taxane or irinotecan in patients with previously treated esophageal squamous cell carcinoma

ovartis Farmacéutica S.A.0 个研究点目标入组 100 人开始时间: 2013年5月16日最近更新: 2016年6月20日

试验速览

暂无简介。

•- Histologically confirmed 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 platinumbased chemotherapy or chemoradiotherapy for localized disease.
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 62
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 35

•- Patients who received prior PI3K inhibitor or anti-HER3 antibody treatment, including bi-specific antibodies with HER3 as one of the targets (patients with prior exposure to pertuzumab or 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 sytem (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 exclusion criteria may apply.

发起方

ovartis Farmacéutica S.A.