A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-611)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 72
- 主要终点
- Recurrence Rate at 2 Years
研究概览
简要总结
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
详细描述
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.
A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).
- If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization [WHO]/International Society of Urologic Pathology [ISUP] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
- If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade [WHO/ISUP classification]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
All patients were to be followed for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(All questions must be answered YES)
- •Has the patient given written informed consent?
- •Is the patient at least 18 years old?
- •Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
- •If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
- •If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
- •Is the patient willing and able to abide by the protocol?
排除标准
- •(All questions must be answered NO)
- •Does the patient have more than 4 bladder tumors?
- •Does any single bladder tumor exceed 3.5 cm in diameter?
- •Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
- •Has the patient ever received Apaziquone?
- •Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
- •Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
- •Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
- •Does the patient have an active urinary tract infection?
- •Does the patient have a bleeding disorder or a screening platelet count < 100 x 10^9/L?
- •Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
- •Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
- •Does the patient have a known immunodeficiency disorder?
- •Has the patient received any investigational treatment within the past 30 days?
- •Is the patient breast feeding?
- •Does the patient have a history of interstitial cystitis?
- •Does the patient have a history of allergy to red color food dye?
- •Has the patient had transitional cell carcinoma of the bladder within the past 4 months?
研究组 & 干预措施
Apaziquone
TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
干预措施: Apaziquone (Drug)
Apaziquone
TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
干预措施: TURBT (Procedure)
Placebo
TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
干预措施: Placebo (Drug)
Placebo
TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
干预措施: TURBT (Procedure)
结局指标
主要结局
Recurrence Rate at 2 Years
时间窗: 2 years
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
次要结局
- Time to Progression(2 years)
- Time to Recurrence(2 years)
- Progression Rate at 2 Years(2 years)
- Number of Recurrences Per Patient(2 years)
- Disease Free Interval(2 years)
- Disease Free Survival(2 years)
- Overall Survival(2 years)