Open-label, single-arm, Phase II study, evaluating safety and efficacy of INCB054828 (Pemigatinib) as adjuvant therapy for molecularly-selected, high-risk patients with urothelial carcinoma who have received radical surgery. A European Association of Urology Research Foundation Phase II Clinical Trial - Adjuvant Pemigatinib in surgically treated high-risk UC

EAU Research Foundation0 个研究点目标入组 2 人2021年6月17日

适应症pT3-4 and/or pN1-3 urothelial carcinoma (UC) of the urinary bladder or upper urinary tract after radical cystectomy /radical nephroureterectomy previously treated with at least three cycles of neoadjuvant cisplatin-based chemotherapy or, if neoadjuvant chemotherapy was not administered, ineligible to receive cisplatin-based adjuvant chemotherapy, with evidence of FGFR3 alterations MedDRA version: 20.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: pT3-4 and/or pN1-3 urothelial carcinoma (UC) of the urinary bladder or upper urinary tract after radical cystectomy /radical nephroureterectomy previously treated with at least three cycles of neoadjuvant cisplatin-based chemotherapy or, if neoadjuvant chemotherapy was not administered, ineligible to receive cisplatin-based adjuvant chemotherapy, with evidence of FGFR3 alterations
发起方: EAU Research Foundation
入组人数: 2
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2021年6月17日

结束日期

2021年11月30日

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

EAU Research Foundation

入排标准

入选标准

•1\. Men and woman, aged 18 years or older with histological evidence of pT3\-4 and/or pN1\-3 urothelial cancer (UC) of the urinary bladder or upper urinary tract after radical cystectomy/radical nephroureterectomy. Patients with mixed histologies are required to have a dominant (i.e. at least 50%) urothelial cell carcinoma pattern
•2\. Previous administration of at least 3 cycles of neoadjuvant cisplatin\-based chemotherapy OR, if neoadjuvant chemotherapy was not administered, ineligibility to receive cisplatin\-based adjuvant chemotherapy based on Galsky’s criteria, that include at least one of the following: (1\) WHO performance status \= 2 and/or (2\) creatinine\-clearance \< 60 ml/min and/or (3\) CTCAE Gr\= 2 hearing loss and/or (4\) CTCAE Gr \= 2 neuropathy
•3\. Evidence of FGFR3 alterations (mutations or gene fusions as specified in protocol) as assessed by a centralized Foundation Medicine test (Foundation One CDx assay). A list of the allowed FGFR alterations is provided the study protocol
•4\. Recovered with no evidence of disease confirmed by radiological images, prior to start of adjuvant therapy within 13 weeks after radical surgery
•5\. WHO performance status of 0, 1 or 2
•6\. Willingness to avoid pregnancy or fathering children. If the patient is male, he must use a condom during sexual intercourse during the treatment period and 240 days thereafter (120 days to eliminate study treatment and 120 days spermatogenesis cycle) plus partner use of a contraceptive method with a failure rate of \<1% per year (See Appendix 1 of the protocol). If the patient is female, and of childbearing potential, she must practice adequate contraception (Appendix 1 of the study protocol)
•for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during the study treatment period and for 150 days after the last study treatment (120 days to eliminate study treatment and 30 days menstruation cycle) (See Appendix 1 of the study protocol for standards of adequate contraceptive methods)
•7\. Written informed consent for screening of tumor tissue and if evidence of FGFR alterations written informed consent for the start of the complete study
•Are the trial subjects under 18? no
•Number of subjects for this age range:

排除标准

•1\. Any previous receipt of a selective FGFR inhibitor
•2\. Presence of primary CIS only
•3\. Presence of another malignancy in the 3 years before enrolment except for basal cell carcinoma or squamous cell carcinoma of the skin, cis of cervix, localised prostate cancer in active surveillance or other non invasive or other indolent malignancy that has undergone potentially curative therapy
•4\. Presence of pregnancy or lactation or not willing to avoid pregnancy or fathering children
•5\. Distant metastases (M1 disease) or presence of radiological evidence of disease at baseline
•6\. Treatment with other investigational drugs, receipt of anticancer medications or radiotherapy of the bladder or upper urinary tract prior to\- or after radical surgery
•7\. Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study Tx
•8\. Abnormal laboratory parameters:
•\- Total bilirubin \= 1\.5 × upper limit of normal (ULN; \= 2\.5 × ULN if Gilbert syndrome);
•\- AST and/or ALT \> 2\.5 × ULN;