Multicenter Investigator-initiated Phase II Trial of E7090 in Patients With Advanced or Recurrent Solid Tumor With Fibroblast Growth Factor Receptor (FGFR) Gene Alteration (FORTUNE Trial)

National Cancer Center, Japan7 个研究点分布在 1 个国家目标入组 75 人2021年6月15日

适应症Advanced or Recurrent Solid Tumors FGFR Gene Alterations

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: Advanced or Recurrent Solid Tumors
发起方: National Cancer Center, Japan
入组人数: 75
试验地点: 7
主要终点: Objective response rate (ORR)
状态: 招募中
最后更新: 7个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).

注册库

clinicaltrials.gov

开始日期

2021年6月15日

结束日期

2028年3月31日

最后更新

7个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

National Cancer Center, Japan

责任方

Sponsor

入排标准

入选标准

•Participants with histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide an archival tumor sample, a residual biopsy sample, or a fresh tumor biopsy sample
•Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available
•Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E defined as below
•Group A: FGFR1-3 fusion
•Group B and E: FGFR1-3 specific activating mutations as below;
•FGFR1: P150S, T340M, R445W, N546K, K656E
•FGFR2: C62Y, A67V, N82K, D101Y, E160K, E163K, M186T, R203H, R210Q, Q212K, R251Q, S252W, P253R, P253L, A264T, W290C, K310R, Y328N, G364E, Y375C, C382R, A389T, V392A, R399Q, H416R, I422V, H544Q, N549H, N549K, N549D, N549S, L560F, K659E, K659N, R664W, E718K, S791T
•FGFR3: G380E, G380R, A391E, K650T, K650E, K650Q, K650N
•Group C: FGFR1-3 activating mutation not applicable to group B, or FGFR1, 2 gene amplification
•For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance

排除标准

•Participants with brain, subdural or leptomeningeal metastases
•Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve
•Positive for either human immunodeficiency virus (HIV) antibody, HBs antigen, or HCV antibody (patients with positive HCV antibody but no detectable HCV-RNA are not excluded)
•Negative for HBs antigen, but positive for HBs antibody or HBc antibody, and also positive for HBV-DNA quantification (not excluded if HBV-DNA is below detection sensitivity)
•Child-Pugh score B or C
•Participants with pericardial effusion, pleural effusion, or ascites requiring treatment
•Have any of the following ocular diseases
•Grade 2 or higher corneal disorders
•Active retinopathy (e.g., age-related macular degeneration, central serous chorioretinal disease, retinal tear)
•Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v5.0), except for alopecia, infertility, and the laboratory test results listed in the inclusion criteria

结局指标

主要结局

Objective response rate (ORR)

时间窗: Baseline up to 3.5 years

Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment.

次要结局

Objective response rate (ORR)(Baseline up to 3.5 years)
Progression-free survival (PFS)(Baseline up to 3.5 years)
Disease control rate (DCR)(Baseline up to 3.5 years)
Overall Survival (OS)(Baseline up to 3.5 years)
Adverse reaction (adverse drug reaction) rate(From the first dose of the investigational product until 30 days after the last dose of study drugs)
Duration of response (DOR)(Baseline up to 3.5 years)
Adverse event (AE) rate(From the first dose of the investigational product until 30 days after the last dose of study drugs)
Time to response (TTR)(Baseline up to 3.5 years)