EUCTR2017-002932-18-GB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. =18yrs 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. Metastatic or surgically unresectable urothelial cancer
- •4. Documented PD, defined as any progression that requires a change in treatment, prior to randomization
- •5.2 Cohort 1: Prior treatment with anti-PD-(L)1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment.Prior treatment with an anti-PD-(L)1 agent can be given as neo-adjuvant, adjuvant, or in metastatic line of treatment as frontline or maintenance therapy:
- •-Subjects could have received anti-PD-(L)1 together with chemotherapy or as maintenance therapy
- •-Subjects could have received prior anti-PD-(L)1 for superficial cancer, or for subjects who have relapsed more than 1 year ago from the last dose of anti-PD-(L)1 in neoadjuvant or adjuvant setting, will not be considered as a prior line and the subject will be eligible
- •-Subjects could have received chemotherapy plus anti-PD-(L)1 in metastatic setting and be eligible
- •Cohort 2: No prior treatment with an anti-PD-(L)1 agent; only 1 line of prior systemic treatment. Note: Subjects who received neoadjuvant or adjuvant chemotherapy or immunotherapy and showed PD within 12m of the last dose are considered to have received systemic therapy in the metastatic setting.
- •6.1 Subjects must meet appropriate molecular eligibility criteria (as determined by central laboratory screening or by local historical test results (from tissue or blood) performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified or regional equivalent laboratory using the following methods: local next-generation sequencing (NGS), direct digital counting methods, or the Qiagen Therascreen FGFR Rotor-Gene Q (RGQ) reverse transcription polymerase chain reaction (RT-PCR) test.
- •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
- •8.3 Adequate bone marrow, liver, and renal function:
- •a. Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding 2wks):
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count >75,000/mm3 (=100,000/mm3 for Cohort 1 subjects at
- •sites choosing vinflunine chemotherapy)
- •Hemoglobin >8.0 g/dL (without transfusion or demonstrate stability, i.e., no significant decline in hemoglobin, for 2wks after transfusion)
- •b. Liver function:
- •-Total bilirubin <1.5 x ULN OR direct bilirubin =ULN for subjects with total bilirubin levels >1.5xULN [=1xULN for Cohort 1 subjects at sites choosing docetaxel chemotherapy]
- •-ALT & AST =2.5x ULN or =5x ULN for subjects with liver metastases [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 either directly measured via 24hr urine collection or calculated using Cockcroft-Gaultd
- •d.Criterion deleted per amdt 3.
- •e. Phosphate: 9.1 Must sign an ICF (or
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). The only allowed exceptions are:
- •urothelial cancer
- •skin cancer treated within the last 24 months that is considered completely cured
- •localized prostate cancer with a Gleason score of 6 (treated within the last 24 months or untreated and under surveillance)
- •localized prostate cancer with a Gleason score of 3+4 that has been treated more than 6m prior to full study screening and considered to have a very low risk of recurrence.
- •3. Symptomatic central nervous system metastases
- •4. Received prior FGFR inhibitor treatment
- •5. Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
- •6.2 Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade
- •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
- •9.1 Known active hepatitis B or C infection (unless polymerase chain reaction[(PCR]-negative [according to local laboratory range] on all available tests for the past 6m).
- •10. Not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, neuropathy, 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 ongoing active infection requiring systemic therapy and uncontrolled ongoing medical conditions.
- •For Cohort 1 Subjects
- •14.2 Criterion modified per Amendment 4.
- •14.3 For those participating ,at sites using docetaxel: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 polysorbate and paclitaxel. At sites using docetaxel, subjects with evidence of interstitial lung disease or active non-infectious pneumonitis are excluded
- •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/atopy would be an exception to this rule.
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