A Multicenter, Multi-Arm, Randomized, Multi-Dose, Placebo-Controlled, Double-Blind, Phase 3 Study of Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant in the Immediate Postoperative Period in Patients Undergoing Transurethral Resection for Non- Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Time to Recurrence
研究概览
简要总结
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder cancer (NMIBC), ≤3.5 centimeters (cm) in diameter, all of which must had been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio.
Arm 1 : One dose of Apaziquone. Arm 2 : Two Doses of Apaziquone. Arm 3 : Placebo. Primary endpoint was to evaluate the Time to Recurrence with either a one instillation of 4 mg apaziquone or two instillations of 4 milligram (mg) apaziquone relative to placebo instillation following TURBT in a participant with NMIBC who received TURBT.
详细描述
This is a Phase 3, randomized, multicenter, multi-arm, placebo-controlled, double-blind study of apaziquone in participants with ≤4 non-muscle invasive bladder tumors, ≤3.5 cm in diameter, all of which must have been fully resected at TURBT.
In addition to Screening, participants underwent an assessment of urothelial carcinoma of the bladder via cystoscopy for clinically apparent tumor Ta, G1-G2.
Following TURBT on Day 1, eligible participants were randomized to one of three treatment arms in a 1:1:1 ratio :
Arm 1 : One Dose of Apaziquone:
- Day 1: administration of 4 mg of apaziquone 60±30 minutes post-TURBT
- Day 15 (±5 days): administration of placebo
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- •Participant had an active concurrent malignancy/life-threatening disease. If there was a history of prior malignancies/life-threatening diseases, the participant was to be disease-free for at least 5 years. Participant with other prior malignancies less than 5 years before study entry could have still been enrolled if they had received treatment resulting in complete resolution of the cancer and currently had no clinical, radiologic, or laboratory evidence of active or recurrent disease.
- •Participant had positive urine cytology for malignancy at Screening.
- •Participant had an active uncontrolled infection, including a urinary tract infection, underlying medical condition, or other serious illness that would impair the ability of the participant to receive protocol treatment.
- •Participant had used any investigational drugs, biologics, or devices within 30 days prior to study treatment or planned to use any of these during the course of the study.
- •Participant had any prior intravesical chemotherapy, immunotherapy, or previous exposure to apaziquone.
- •Participant had or has ever had
- •Upper tract Transitional Cell Carcinoma (TCC).
- •Urethral tumor (prostatic urethra included).
- •Any invasive bladder tumor known to be other than tumor Ta, G1-G
- •Any evidence of lymph node or distant metastasis.
- •Any bladder tumor with histology other than TCC.
- •Carcinoma in situ (CIS).
- •Participant had a tumor in a bladder diverticulum.
- •Participant had received any pelvic radiotherapy (including external beam and/or brachytherapy.)
- •Participant had a bleeding disorder or a screening platelet count <100×10^9/L.
- •Participant had screening hemoglobin <10 milligrams per deciliter (mg/dL).
- •Participant had any unstable medical condition that would make it unsafe to undergo TURBT.
- •Participant had a history of interstitial cystitis.
- •Participant had a history of allergy to red color food dye.
- •For a participant with a recurrent tumor, the participant had at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and screening cystoscopic examination.
- •Participant was pregnant or breast-feeding.
研究组 & 干预措施
1 Dose Apaziquone
Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
干预措施: Apaziquone (Drug)
1 Dose Apaziquone
Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post transurethral resection of bladder tumor (TURBT) on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
干预措施: Placebo (Other)
2 Dose Apaziquone
Participants were randomized to receive first dose of 4 mg of apaziquone by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of 4 mg of apaziquone by intravesical administration via an indwelling catheter on Day 15 (±5 days).
干预措施: Apaziquone (Drug)
Placebo
Participants were randomized to receive first dose of matching placebo by intravesical administration into the bladder at 60 ± 30 minutes post TURBT on Day 1 via an indwelling 100% Silicone Foley catheter. Followed by second dose of matching placebo by intravesical administration via an indwelling catheter on Day 15 (±5 days).
干预措施: Placebo (Other)
结局指标
主要结局
Time to Recurrence
时间窗: From randomization to the date of first histologically confirmed recurrence of bladder cancer (up to 1.5 years)
Time from randomization to the date of histologically confirmed recurrence of bladder cancer. A recurrence was defined as any pathologically confirmed disease of ≥Ta tumor histology or carcinoma in situ (CIS) post-treatment.
次要结局
- Time to Progression(From randomization to the date of first disease progression (up to 1.5 years))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and Death(Up to 1.5 Years)
- 2-Year Recurrence Rate(2 years)
- 1-Year Recurrence Rate(1 year)