NCT05216120撤回2 期
Efficacy and Safety of Pemigatinib in Subjects With Advanced Metastatic or Surgically Unresectable Adenosquamous Carcinoma of the Pancreas (ASCP) Who Have Progressed On Previous Therapy
HonorHealth Research Institute1 个研究点 分布在 1 个国家开始时间: 2022年6月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall response rate of pemigatinib
研究概览
简要总结
The purpose of this research is to determine the benefit of pemigatinib in patients with advanced metastatic or surgically unresectable adenosquamous carcinoma of the pancreas who have progressed on previous therapy.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age; male or female
- •Capable of providing informed consent and complying with trial procedures.
- •Histologically or cytologically confirmed adenosquamous carcinoma of the pancreas (ASCP)
- •Metastatic or unresectable ASCP patients who have progressed on at least one line of therapy
- •FGFR gene fusion, mutation, or rearrangement as determined by standard CLIA-certified FDA-approved genomic panel (e.g. Ashion, Caris, FoundationOne etc.).
- •Radiographically measurable or evaluable disease according to RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Life expectancy ≥ 12 weeks.
- •Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
- •Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment (including dose interruptions), and while on study treatment and for 1 week following discontinuation from study treatment ;and,
- •Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and at the end of study participation. This applies even if the subject practices true abstinence* from heterosexual contact.
- •Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 1 week following discontinuation from study treatment, even if he has undergone a successful vasectomy.
排除标准
- •Patients that have received prior treatment with 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.
- •Exposure to any therapeutic or investigational agent(s) within 3 weeks prior to initiation of study treatment.
- •Major surgery within 4 weeks prior to initiation of study treatment.
- •Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results.
研究组 & 干预措施
Pemigatinib
Experimental
Participants will be provided with a bottle of pemigatinib tablets on Day 1 of each cycle (one cycle = 21 days). A bottle contains 4.5 mg X 42 tablets total. Each pemigatinib bottle is sufficient for one cycle. Resupply will be provided as necessary on Day 1 of each cycle.
干预措施: Pemigatinib 4.5 MG (Drug)
结局指标
主要结局
Overall response rate of pemigatinib
时间窗: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
Overall response rate of pemigatinib in patients with advanced metastatic or surgically unresectable ASCP who have progressed on previous therapy
次要结局
- Progression free survival (PFS)(Initiation of study treatment up to study completion, up to 2 years)
- Overall survival (OS)(Initiation of study treatment up to study completion, up to 2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE V4.0(Initiation of study treatment up to 12 cycles (each cycle is 21 days))
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid TumorsSolid TumorFGF Receptor Gene MutationFGF AmplificationFGF Receptor Gene Family RearrangementFGF Receptor Gene TranslocationNCT06022289Tianjin Medical University Second Hospital20
终止
2 期
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)Advanced or Metastatic Solid TumorsFGFR MutationsFGFR TranslocationsNCT04003623Incyte Corporation1
终止
2 期
Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)Solid Tumor MalignancyNCT03822117Incyte Corporation111
已完成
2 期
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)CholangiocarcinomaNCT02924376Incyte Corporation147
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)MPN (Myeloproliferative Neoplasms)NCT03011372Incyte Corporation47