A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Median Progression Free Survival
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.
详细描述
A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged 25 or over
- •Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
- •Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
- •At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
- •Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
排除标准
- •Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD
- •Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
- •Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
- •With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
- •Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
- •Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.
研究组 & 干预措施
AZD4547
AZD4547 taken orally in tablet formation, 80mg b.d., in a 2 week on, 1 week off schedule
干预措施: AZD4547 (Drug)
Paclitaxel
Paclitaxel - 80mg/m² as a 1 hour infusion given weekly on days 1, 8 and 15 of a 28 day cycle (up to the maximum number of cycles per local practice)
干预措施: paclitaxel (Drug)
结局指标
主要结局
Median Progression Free Survival
时间窗: Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)
PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).
次要结局
- Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)(Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week))
- Objective Response Rate(Week 8 (±1 week) and then every 8 weeks (±1 week))
- Percentage Change From Baseline at Week 8 in Target Lesion Size(Baseline, Week 8 (±1 week))
- Percentage of Patients Without Progressive Disease at 8 Weeks(Week 8 (±1 week))