EUCTR2017-002932-18-HU进行中（未招募）1 期
A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations - THOR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
- •2. Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components (<50% overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
- •3. Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)
- •4. Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization
- •5. Only one line of prior treatment for metastatic urothelial cancer. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined in criterion 4), within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting
- •Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for subjects with documented cisplatin ineligibility)
- •Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)
- •6. Subjects must meet appropriate molecular eligibility criteria (as determined by central laboratory screening): Tumors must have at least 1 of the following translocations: FGFR2-BICC1, FGFR2-CASP7, FGFR3-TACC3, FGFR3-BAIAP2L1; or 1 of the following FGFR3 gene mutations: R248C, S249C, G370C, Y373C
- •7. ECOG performance status Grade 0, 1, or 2 (Attachment 1)
- •8. Adequate bone marrow, liver, and renal function:
- •a. Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding 2 weeks):
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count >75,000/mm3
- •Hemoglobin >8.0 g/dL (without transfusion or demonstrate stability, i.e., no significant decline in hemoglobin, for 2 weeks after transfusion)
- •b. Liver function:
- •Total bilirubin <1.5 x institutional upper limit of normal (ULN), unless known to have Gilbert's disease [=1xULN for Cohort 1 subjects at sites choosing docetaxel chemotherapy]
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x institutional ULN [ALT and AST both =1.5xULN and alkaline phosphatase =2.5xULN for Cohort 1 subjects at sites choosing docetaxel chemotherapy]
- •c. Renal function: Creatinine clearance >30 mL/min/1.73 m2 either directly measured via 24-hour urine collection or calculated using Cockcroft-Gault (Attachment 2)
- •d. Electrolytes: Potassium within institutional normal limits
- •e. Phosphate: 9. Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •10. A woman of childbearing potential who is sexually active must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) at Screening (urine or serum)
- •11. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
- •For women of childbearing potential:
- •practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly)
- •Examples of highly effective contraceptives include
- •- user-independent methods:
- •implantable progestogen-only hormone contraception associated wit
排除标准
- •For All Subjects
- •1. Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization
- •2. Active malignancies (ie, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)
- •3. Symptomatic central nervous system metastases
- •4. Received prior FGFR inhibitor treatment
- •5. Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- •6. Corneal or retinal abnormality likely to increase the risk of eye toxicity, i.e.:
- •a. History of central serous retinopathy (CSR) or retinal vascular occlusion (RVO)
- •b. Active wet, age-related macular degeneration (AMD)
- •c. Diabetic retinopathy with macular edema (non-proliferative)
- •d. Uncontrolled glaucoma (per local standard of care)
- •e. Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration.
- •7. History of uncontrolled cardiovascular disease including:
- •a. unstable angina, myocardial infarction, ventricular fibrillation, Torsades de Pointes, cardiac arrest, or known congestive heart failure Class III-V (Attachment 3) within the preceding 3 months; cerebrovascular accident or transient ischemic attack within the preceding 3 months
- •b. QTc prolongation as confirmed by triplicate assessment at screening (Fridericia; QTc >480 milliseconds)
- •c. Pulmonary embolism or other venous thromboembolism (VTE) within the preceding 2 months
- •8. Known active AIDS (human immunodeficiency virus (HIV) infection), unless the subject has been on a stable anti retroviral therapy regimen for the last 6 months or more, has had no opportunistic infections in the last 6 months, and has CD4 count >350
- •9. Known active hepatitis B or C infection (subjects with history of hepatitis C infection but negative hepatitis C virus polymerase chain reaction[(PCR] test and subjects with JNJ42756493 (Erdafitinib) hepatitis B with positive hepatitis B surface antibody are allowed)
- •10. Not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, Grade 1 neuropathy, Grade 1-2 hearing loss)
- •11. Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
- •12. Major surgery within 4 weeks before randomization
- •13. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Examples include poorly controlled diabetes (hemoglobin A1c >8), or ongoing active infection requiring intravenous antibiotics
- •For Cohort 1 Subjects
- •14. Depending on the chemotherapy regimen to be used at the participating site, has a history of severe hypersensitivity reaction (eg, generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to either docetaxel or to other drugs formulated with polyoxyethylated castor oil, or to vinflunine or other vinca alkaloids
- •For Cohort 2 Subjects
- •15. Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents. Subjects with vitiligo, diabetes Type I, or resolved childhood asthma/
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