CTRI/2021/08/036009进行中（未招募）2 期
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 5
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator’s Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed.
- •Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions.
- •Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants.
- •Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only).
- •Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-
- •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.
- •A woman of childbearing potential must have a negative pregnancy test (beta-hCG [beta-human chorionic gonadotropin]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3).
- •Adequate bone marrow, liver, and renal function as specified in the protocol.
排除标准
- •Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder.
- •Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder.
- •Prior treatment with an FGFR inhibitor.
- •Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy.
- •Current central serous retinopathy or retinal pigment epithelial detachment of any grade.
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: Recurrence-Free Survival (RFS)
次要结局
- Time to Disease Worsening(Up to 4 years)
- Overall Survival(Up to 4 years)
- Time to Progression(Up to 4 years)
- Disease-Specific Survival(Up to 4 years)
- Recurrence-Free Survival(Months 6, 12, and 24)
- Recurrence-Free Survival 2 (RFS2)(Up to 4 years)
- RFS by Central Histopathologic Review(Up to 4 years)
- Plasma Concentration of Erdafitinib(Cycle 1 Day 14, Cycle 2 Day 1 (each cycle is of 28)
- Number of Participants with Adverse events(Up to 4 years)
- Change from Baseline in Patient’s Global(Impression of Change (of cancer) (PGIC))
- Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life(Questionnaire (EORTC QLQ) -C30)
- Change from Baseline in EORTC QLQ- Non-(Muscle-Invasive Bladder Cancer (NMIBC) 24)
- Change from Baseline in EuroQol European Quality(of Life – 5 Dimensions-5 Levels (EQ-5D-5L))
研究者
研究点 (5)
Loading locations...
相似试验
已完成
2 期
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)Urinary Bladder NeoplasmsNCT04172675Janssen Research & Development, LLC107
进行中（未招募）
1 期
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions.EUCTR2019-002449-39-DEJanssen-Cilag International NV280
进行中（未招募）
1 期
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions.Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or FusionsCohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or FusionsMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002449-39-BEJanssen-Cilag International NV280
已完成
2 期
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guerin (BCG) and Recurred with High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)JPRN-jRCT2080225050Janssen Pharmaceutical K.K.107
进行中（未招募）
1 期
A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions.Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or FusionsCohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or FusionsMedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002449-39-CZJanssen-Cilag International NV280