NCT01202591已完成1 期
A Randomised Double-blind Phase IIa Study (With Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients With FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment With Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (GLOW)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
- •Histological confirmation of Breast Cancer with documented ER+ receptor status
- •Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
- •Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
- •Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits
排除标准
- •Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.
- •More than 1 prior regimen of chemotherapy for breast cancer
- •ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
- •History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
- •Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
研究组 & 干预措施
AZD4547 + exemestane
Experimental
Safety run-in: AZD4547 plus exemestane
干预措施: AZD4547 (Drug)
AZD4547 + exemestane
Experimental
Safety run-in: AZD4547 plus exemestane
干预措施: Exemestane (Drug)
AZD4547 + fulvestrant
Experimental
A Randomised phase IIa: AZD4547 plus fulvestrant
干预措施: AZD4547 (Drug)
AZD4547 + fulvestrant
Experimental
A Randomised phase IIa: AZD4547 plus fulvestrant
干预措施: Fulvestrant (Drug)
Placebo + fulvestrant
Placebo Comparator
Randomised phase IIa: Matching placebo plus fulvestrant
干预措施: Placebo (Drug)
Placebo + fulvestrant
Placebo Comparator
Randomised phase IIa: Matching placebo plus fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)
时间窗: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
次要结局
未报告次要终点
研究者
研究点 (1)
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