A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced/Metastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Dose escalation : Dose Limiting Toxicity (DLT)
研究概览
简要总结
Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BYL719 and paclitaxel
All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel
干预措施: BYL719 (Drug)
BYL719 and paclitaxel
All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Dose escalation : Dose Limiting Toxicity (DLT)
时间窗: Cycle 1 (28 days)
A dose-limiting toxicity (DLT) is an adverse event or abnormal laboratory value assessed as being unrelated to disease, disease progression, inter-current illness, or concomitant medications, and that occurs within the first cycle of treatment with BYL719 plus paclitaxel and meets any of the pre-defined criteria.
Dose expansion : Number of patients with adverse events as a measure of safety and tolerability
时间窗: Screening, every 28 days until 30 days after last dose
type, intensity, severity and seriousness of adverse events according to the NCI CTC AE v4.03. Dose interruptions, reductions and dose intensity.
次要结局
- Dose escalation : BYL719 and Paclitaxel Plasma concentrations(Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 1 Day 9)
- Dose expansion: Clinical benefit Rate in the breast cancer cohort(Baseline, every 8 weeks (Breast cancer patients) from start of treatment until first documented disease progression up to 2 years)
- Dose expansion : Duration of Response(Baseline, every 6 weeks (HNSCC patients) or every 8 weeks (breast cancer patients) from start of treatment until first documented disease progression up to 2 years)
- Dose expansion: Plasma pharmacokinetics of BYL719 given in combination with paclitaxel in breast cancer and HNSCC patients(Cycle 1 Day 1, Cycle 1 Day 8, Cycle 2 Day 15, and Day 1 of each subsequent Cycle)
- Dose escalation:Number of patients with adverse events as a measure of safety and tolerability(Screening, every 28 days until 30 days after last dose)
- Dose expansion: Overall response rate(Baseline, every 6 weeks (HNSCC patients) or every 8 weeks (Breast cancer patients) from start of treatment until first documented disease progression up to 2 years)
- Dose expansion: Progression free survival(Baseline, every 6 weeks (head-and-neck squamous cell carcinoma (HNSCC) patients) or every 8 weeks (Breast cancer patients) from start of treatment until first documented disease progression up to 2 years)