A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
研究概览
简要总结
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed cholangiocarcinoma.
- •Radiographically measurable or evaluable disease per RECIST v1.
- •Tumor assessment for FGF/FGFR gene alteration status.
- •Documented disease progression after at least 1 line of prior systemic therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Life expectancy ≥ 12 weeks.
排除标准
- •Prior receipt of a selective FGFR inhibitor.
- •History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
- •Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
- •Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
研究组 & 干预措施
Cohort A Pemigatinib
Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
干预措施: Pemigatinib (Drug)
Cohort B Pemigatinib
Pemigatinibin subjects with other FGF/FGFR alterations
干预措施: Pemigatinib (Drug)
Cohort C Pemigatinib
Pemigatinib in subjects negative for FGF/FGFR alteration
干预措施: Pemigatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
时间窗: up to 1527 days
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
次要结局
- ORR in All Participants With FGF/FGFR Alterations(up to 1527 days)
- ORR in Participants Negative for FGF/FGFR Alterations(up to 143 days)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 1584 days)
- Overall Survival(up to 51.32 months)
- Vc/F of Pemigatinib(Predose; 1-2 hours post-dose; 4-12 hours post-dose)
- Vp/F of Pemigatinib(Predose; 1-2 hours post-dose; 4-12 hours post-dose)
- Progression-free Survival (PFS)(up to 50.17 months)
- Disease Control Rate (DCR)(up to 1527 days)
- First-order Absorption Rate Constant (ka) of Pemigatinib(Predose; 1-2 hours post-dose; 4-12 hours post-dose)
- CL/F of Pemigatinib(Predose; 1-2 hours post-dose; 4-12 hours post-dose)
- ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions(up to 424 days)
- Duration of Response (DOR)(up to 47.11 months)