NCT01922583已完成2 期
A Multi-center Phase II Study of AUY922 in Patients With Stage IV Non-small Cell Lung Cancer (NSCLC) With Driver Molecular Alterations Other Than Sensitive EGFR Mutation, Who Have Progressed After One Line of Systemic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Objective response rate
研究概览
简要总结
This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC.
详细描述
Study Design:
This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC (n = 9 x 7)
Objectives:
Primary objective(s):
To define the objective response rate by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven diagnosis of stage IV NSCLC (AJCC 7th) which had been treated with one systemic therapy.
- •One of the molecular alterations as follows:
- •EGFR mutations in exon 20 T790M.
- •EGFR mutations in exon 20; in-frame duplication and/or insertion (e.g. A767_V769dupASV or H773_V774insH) or point mutations other than T790M; or other uncommon mutations.
- •HER2 mutation in exon 20; in-frame duplication and/or insertion (e.g. YVMA 776-779 ins).
- •BRAF mutation in exon 15; point mutation (e.g. V600E) or in exon 11; point mutation (e.g. G469A, D594G).
- •ALK translocation resulting in EML4-ALK, KIF5B-ALK, or TFG-ALK fusion as determined by an ALK break apart FISH assay and defined by an increase in the distance of 5' and 3' ALK probes (split 5'-3') or the loss of the 5' probe (single 3'). Positive ALK results from other methods such as immunohistochemistry (IHC) or reverse transcriptase polymerase chain reaction testing may also be acceptable.
- •ROS1 translocation resulting in CD74-ROS1 or SLC34A2-ROS1, etc.
- •RET translocation resulting in KIF5B-RET fusion, etc.
- •Patients with brain metastases are eligible if treated and neurologically stable for at least 2 weeks and is not taking any steroid.
- •Any prior chemotherapy, targeted therapy (monoclonal antibodies), or major surgeries must have had completed at least 4 weeks before initiation of study medication. Any prior targeted therapy (tyrosine kinase inhibitors), radiotherapy or minor surgeries must have had completed at least 2 weeks before initiation of study medication. Any acute toxicity must have recovered to <=grade 1 (except for alopecia).
- •Patients must have measurable or evaluable disease as per RECIST version 1.
- •20 years of age or older
- •ECOG performance status 0-2
- •Adequate organ function as defined by the following criteria:
- •Bone marrow function
- •Hemoglobin >=8.0 g/dL
- •Absolute neutrophil count (ANC) >=1500/uL
- •Platelets >=100,000/uL
- •Hepatic function
- •Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) <=3.0 x upper limit of normal (ULN) or AST and ALT <=5.0 x ULN if there is liver metastasis
- •Total serum bilirubin <=1.5 x ULN Renal function
- •Creatinine <= 1.5 x ULN or creatinine clearance >=45 mL/min
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
- •Patients must use effective methods of contraception during the study period and for at least 90 days following study completion (excluding surgically sterile male patients, surgically sterile or postmenopausal female patients).
排除标准
- •Currently on other therapeutic clinical trials
- •Prior treatment of HSP90 inhibitors
- •Any of the following within 3 months before initiation of study medication
- •Myocardial infarction
- •Unstable angina
- •Coronary artery bypass graft
- •Congestive heart failure NYHA functional class III or IV
- •Cerebral vascular accident
- •Transient ischemic attack
- •Uncontrolled hypertension at screening
- •Ongoing cardiac arrhythmias of NCI CTCAE grade >=2
- •Active infection requiring antibiotics
- •Pregnancy or breast feeding
- •Prior malignancy within the past 5 years (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, and early prostate cancer).
- •Active hepatitis B or C; positive HIV test result.
研究组 & 干预措施
Vial
Experimental
AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression
干预措施: AUY922 (Drug)
结局指标
主要结局
Objective response rate
时间窗: Patients will be followed up for 2 years(post disease progression)
To define the by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC
次要结局
- Efficacy, progression-free survival (PFS)(Patients will be followed up for PFS and OS for 2 years.(post disease progression))
- overall survival (OS)(Patients will be followed up for OS for 2 years.(post disease progression))
研究者
研究点 (3)
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