2023-507684-19-00招募中3 期
Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 78
- 主要终点
- DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first
研究概览
简要总结
To compare DFS between Group A and Group B.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: • Ta LG/G1: primary or recurrent • Ta LG/G2: primary or recurrent And ≥1 of the following risk factors: • Multiple Ta LG tumors • Solitary LG tumor ≥3 cm • Early recurrence (≤1 year) • Frequent recurrence (>1 per year) • Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) Note: Mixed histology tumors are allowed if percentage of variant histology and subtype of variant histology are consistent with an LG tumor.
- •Have a susceptible FGFR mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
- •Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy.
排除标准
- •Histologically confirmed diagnosis of HR NMIBC (defined as HG/G2 or HG/G3 Ta and T1, or CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.
- •Has or had urothelial carcinoma outside of the urinary bladder (ie, urethra, ureter, or renal pelvis, N+, M+) or has a histological variant of UC. Ta/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and without any evidence of disease following nephroureterectomy.
- •Received an investigational treatment for bladder cancer after TURBT for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study.
- •Received adjuvant intravesical chemotherapy within 6 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy per institutional guidelines (is not considered adjuvant therapy (and no washout period is required for this single dose).
- •Received prior treatment with an FGFR inhibitor
结局指标
主要结局
DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first
DFS will be measured as the time from randomization to the date of the first documented recurrence of NMIBC of any grade, disease progression, or death due to any cause, whichever occurs first
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (78)
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