EUCTR2010-023377-19-BG进行中（未招募）不适用
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 (Shine study) - SHINE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 240
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
- •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 first line treatment for advanced/metastatic gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy
- •At least one lesion, not previously irradiated, that at baseline is equal to or larger than 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
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in Cremaphor 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 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.
研究者
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已完成
2 期
Safety and Efficacy of AZD4547 Versus Paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer Patients (SHINE)CTRI/2012/02/002432AstraZeneca AB1
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