EUCTR2011-006017-34-FR进行中（未招募）1 期
A phase Ib dose escalation/randomized phase II, multicenter, open-label study of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years
- •- Patients with histologically/cytologically-confirmed HNSCC
- •- Patients must be resistant to platinum-based chemotherapy, or be ineligible or intolerant to platinum-based therapy per medical history
- •- For Phase Ib only, at least 1 prior therapy for recurrent or metastatic disease
- •- For Phase II only, a maximum of 1 prior therapy for recurrent or metastatic disease
- •- Prior cetuximab or another EGFR-targeted antibody therapy is allowed only if administered in the induction setting, or concurrently with radiation in the curative setting, with the last dose of cetuximab administered at least 12 months prior to starting the study treatment
- •- Availability of a representative tumor specimen (primary or metastatic, archival or fresh)
- •- At least one measurable or non-measurable (as per RECIST 1.1 criteria) lesion is required for patients enrolled in Phase Ib. Measurable disease as determined by RECIST v1.1 is required for Phase II patients.
- •- World Health Organization (WHO) Performance Status (PS) = 2.
- •- Adequate organ function and laboratory parameters
- •- Negative serum pregnancy test
- •Other inclusion criteria may apply as per protocol
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior treatment with PI3K-inhibitors
- •- Patients with a prior serious infusion reaction to cetuximab
- •- Patients with primary central nervous system (CNS) tumor or CNS tumor involvement
- •- Clinically significant cardiac disease or impaired cardiac function
- •- Patients with diabetes mellitus
- •- History of another malignancy within 2 years prior to starting study treatment
- •- Pregnant or nursing (lactating) women
- •Other exclusion criteria may apply as per protocol
研究者
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