NL-OMON40123已完成不适用
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 - BYL719 and cetuximab in head and neck carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •- 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 tumor specimen (primary or metastatic, archival or fresh)
- •- At least one measurable or non-measurable lesion is required for patients enrolled in Phase Ib. Measurable disease is required for Phase II patients (as per RECIST 1.1 criteria)
- •- WHO Performance Status (PS) * 2.
- •- Adequate organ function and laboratory parameters
- •- Negative serum pregnancy test ;NEW
- •-For Arm 3, prior cetuximab incl. platinum as therapeutic setting and disease progression documented within 9 months of the last dose of cetuximab administered in that setting.
- •- Patients enrolled in Arm 3 must have amenable sites to biopsy;More detailed inclusion criteria see protocol section 5.2
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
- •- Impaired GI function or GI disease that may signifincant alter the absorption of oral BYL719
- •- History of another malignancy within 2 years prior to starting study treatment ;More detailed exclusion criteria see protocol section 5.3
研究者
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