NCT04238715已完成2 期
A Multicenter, Open-Label, Phase 2 Trial of E7090 in Subjects With Unresectable Advanced or Metastatic Cholangiocarcinoma With FGFR 2 Gene Fusion
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
- 63
- 试验地点
- 56
- 主要终点
- ORR
研究概览
简要总结
The primary purpose of the study is to assess the objective response rate (ORR) of E7090 by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 based on independent imaging review (IIR) in participants with unresectable cholangiocarcinoma with FGFR2 gene fusion who failed gemcitabine-based combination chemotherapy.
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
- •Participants with a histologically or cytologically diagnosis of intrahepatic or perihilar cholangiocarcinoma who agree to provide archival tumor sample or residual biopsy sample, or agree with tumor biopsy.
- •Participants who have confirmed FGFR2 gene fusion of tumor by fluorescence in situ hybridization (FISH) in central laboratory. FGFR2 gene fusion confirmed by the same FISH assay in another test/study will be discussed with the sponsor and agreed on a case by case basis.
- •Participants with surgically unresectable or advanced/metastatic disease who have received at least one prior chemotherapy including gemcitabine-based combination chemotherapy (example: gemcitabine and cisplatin)
- •a. Prior adjuvant chemotherapy is allowed if relapse was within 6 months after last administration.
- •Measurable disease meeting the following criteria:
- •At least 1 lesion of >=1.0 centimeter (cm) in the longest diameter for a non-lymph node or >=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI).
- •Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
- •Corrected serum calcium less than or equal to (<=) upper limit of normal (ULN).
- •Phosphate <=ULN.
- •Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG).
- •Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug.
- •Washout period required from the end of prior treatment to the start of E7090 administration will be as follows
- •Antibody and other investigational drugs : >=4 weeks
- •Prior chemotherapy (except small-molecule targeted therapy), surgical therapy, radiation therapy：>=3 weeks
- •Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=2 weeks
排除标准
- •Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
- •Concomitant active infection requiring systemic treatment (except hepatitis B or C virus-infected participants who are under anti-viral treatment).
- •Participants who test positive for human immunodeficiency virus (HIV antibody) at Screening
- •Child-Pugh score B or C.
- •Moderate or severe ascites extending from the pelvis to the liver surface.
- •Following ocular disorders
- •Current evidence of Grade 2 or higher corneal disorder
- •Current evidence of active macula disorder (example: age-related macular degeneration, central serous chorioretinal disease)
- •Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v4.03), except for alopecia, infertility and the adverse events listed in inclusion criteria.
- •Participants with prior therapy targeting FGFR
- •Participants who need the use of drugs or foods that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A4 during study treatment (there must be a time interval of >= 7 days since the final use of these drugs or foods by the start of study treatment).
研究组 & 干预措施
E7090 140 mg
Experimental
Participants will receive E7090 140 mg (milligram), tablets orally once daily (QD), in 28-days treatment cycle until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination.
干预措施: E7090 (Drug)
结局指标
主要结局
ORR
时间窗: From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years 2 months)
The ORR will be assessed by IIR based on RECIST version 1.1. ORR is defined as a percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). CR: disappearance of all (targeted and non-target \[NT\]) lesions. PR: For PR, longest diameter will be used for non-lymph target lesions but short axis is measured for lymph lesions. PR: greater than or equal to (\>=) 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline, associated to non-progressive disease (non-PD) response for (NT) lesions.
次要结局
- Progression Free Survival (PFS)(From the date of first dose to the date of first documentation of disease progression or date of death from any cause, whichever occurs first (up to approximately 6 years 2 months))
- Duration of Response (DOR)(From the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first (up to approximately 6 years 2 months))
- Time to Response (TTR)(from the date of first study dose to the date of first documentation of CR or PR (up to approximately 6 years 2 months))
- Overall Survival (OS)(From the date of first dose to the date of death from any cause (up to approximately 6 years 2 months))
- Disease Control Rate (DCR)(From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years 2 months))
- Clinical Benefit Rate (CBR)(From first dose of study drug until disease progression, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 6 years 2 months))
研究者
研究点 (56)
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