A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy - Rogaratinib vs chemotherapy in patients with urothelial carcinoma

Bayer0 个研究点目标入组 41 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Bayer
入组人数: 41

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•- Existence of archival or fresh biopsy for FGFR testing
•- FGFR testing of patients will be performed at the investigators* discretion up to a max. of 90 days prior to start of screening. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.
•- Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
•-- Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)
•-- Locally advanced (T4b, any N; or any T, N 2*3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).
•- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
•- Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/neoadjuvant platinum-containing chemotherapy, progression had to occur within 12
•months of treatment.
•- High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen
•- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI

排除标准

•- Previous or concurrent cancer except
•-- cervical carcinoma in situ
•-- treated basal-cell or squamous cell skin carcinoma
•-- any cancer curatively treated > 3 years before randomization
•-- Curatively treated incidental prostate cancer (T1/T2a)
•- Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
•- More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma
•- Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine
•- Unresolved toxicity higher than National Cancer Institute*s Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia, anemia and/or hypothyroidism
•- History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:
•-- Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
•-- Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)
•-- Myocardial infarction (MI) within past 6 months beforerandomization
•-- Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
•- Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization
•- Current evidence of endocrine alteration of calcium Phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
•- Any hemorrhage / bleeding event * CTCAE v.4.03 Grade 3 within 4 weeks before randomization
•- Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion

研究者

发起方

Bayer

相似试验

进行中（未招募）

1 期

Phase 2/3 study of rogaratinib (pan FGFR inhibitor) vs chemotherapy in patients with locally advanced or metastatic urothelial carcinoma with a high amount of specific cell growth factor receptors 1 and 3 (FGFR1 and 3) in the tumor cellsmRNA FGF receptor 1 and 3 positive locally advanced or metastaticurothelial carcinoma progressed after prior platinum-containingchemotherapyMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864

EUCTR2016-004340-11-HUBayer AG, D-51368 Leverkusen, Germany1,627

进行中（未招募）

1 期

EUCTR2016-004340-11-ITBAYER HEALTHCARE AG1,627

进行中（未招募）

1 期

EUCTR2016-004340-11-DKBayer AG, D-51368 Leverkusen, Germany1,627

进行中（未招募）

1 期

Phase 2/3 study of rogaratinib (pan FGFR inhibitor) vs chemotherapy in patients with locally advanced or metastatic urothelial carcinoma with a high amount of specific cell growth factor receptors 1 and 3 (FGFR1 and 3) in the tumor cells.mRNA FGF receptor 1 and 3 positive locally advanced or metastaticurothelial carcinoma progressed after prior platinum-containingchemotherapyMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864

EUCTR2016-004340-11-CZBayer AG1,627

进行中（未招募）

1 期

EUCTR2016-004340-11-FRBayer AG, D-51368 Leverkusen, Germany1,627