NCT02720367已完成1 期
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects With Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety as defined by the number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0
研究概览
简要总结
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis and transurethral resection of bladder tumors (TURBT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •A documented history of histologically-confirmed low or intermediate risk urothelial carcinoma of the bladder, excluding carcinoma in situ (pTis), pathologic stage pT1 (invasive into lamina propria) and high-Grade disease, judged not to be muscle infiltrating (pT2 or greater) and accessible for resection.
- •Adequate laboratory parameters.
- •Screening urinalysis showing no clinically significant abnormalities except those attributable to bladder cancer.
- •Not undergoing active treatment in last 3 months for prior or concurrent neoplastic disease and have fully recovered from treatment effects. Patients undergoing concurrent hormonal therapy treatment for prostate cancer will be allowed to enroll.
排除标准
- •Exposure to BCG therapy and/or any other intravesical. chemotherapeutic agent less than 1 year prior to enrollment, except single postoperative instillations.
- •Absence of visible tumor at Screening.
- •Any previous exposure to intravesical gemcitabine instillations within the past 12 months.
- •Presence of any bladder or urethral anatomical feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-200 (i.e. bladder diverticula, complete incontinence).
- •Patients with a high-Grade urine cytology at recurrence.
- •Currently receiving other systemic or intravesical chemotherapy.
- •Pelvic radiotherapy administered within 6 months prior to enrollment. Patients who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no cystoscopic evidence or clinical symptoms of radiation cystitis.
- •Bladder Post-Void Residual Volume (PVR) of > 250-mL.
- •Active, uncontrolled urogenital bacterial, viral, or fungal infections, including urinary tract infection. Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study.
- •History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
- •Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses ≤5 mg daily.
- •Female subject who is pregnant (as verified by urine test at time of screening) or lactating, or of childbearing potential and not using acceptable methods of contraception.
- •Unwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.
- •Other unspecified reasons that, in the opinion of the investigator or TARIS, make the patient unsuitable for enrollment.
研究组 & 干预措施
7-Day Regimen
Experimental
TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 7. TAR-200 releases gemcitabine gradually during the 7 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 28, which is the day of the TURBT.
干预措施: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 (Drug)
21-Day Regimen
Experimental
TAR-200 is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 21. TAR-200 releases gemcitabine gradually during the 21 day indwelling time. A second TAR-200 is placed in the bladder on Study Day 21 and is removed on Study Day 42.
干预措施: Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200 (Drug)
结局指标
主要结局
Safety as defined by the number of participants with treatment emergent adverse events (TEAEs) coded with MedDRA and graded for severity with CTCAE v4.0
时间窗: From the point of signing the informed consent form through last study visit, up to 59 days.
次要结局
- Percentage of participants who are tolerant of TAR-200 indwelling (Arm 1)(From Day 21 up to Day 28)
- Number of participants who are tolerant of TAR-200 indwelling (Arm 1)(From Day 21 up to Day 28)
- Cmax, plasma dFdU (Arm 1)(From Day 0 up to Day 32)
- Tmax, plasma dFdU (Arm 1)(From Day 0 up to Day 32)
- Cavg, plasma dFdU (Arm 1)(From Day 0 up to Day 32)
- Cmax, plasma dFdC (Arm 1)(From Day 0 up to Day 32)
- Tmax, plasma dFdC (Arm 1)(From Day 0 up to Day 32)
- Cavg, plasma dFdC (Arm 1)(From Day 0 up to Day 32)
- Cmax, urine dFdU (Arm 1)(From Day 0 up to Day 32)
- Tmax, urine dFdU (Arm 1)(From Day 0 up to Day 32)
- Cavg, urine dFdU (Arm 1)(From Day 0 up to Day 32)
- Percentage of participants who are tolerant of TAR-200 indwelling (Arm 2)(From Day 21 up to Day 42)
- Cmax, urine dFdC (Arm 1)(From Day 0 up to Day 32)
- Cavg, urine dFdC (Arm 1)(From Day 0 up to Day 32)
- Cmax, plasma dFdU (Arm 2)(From Day 0 up to Day 47)
- Cavg, plasma dFdU (Arm 2)(From Day 0 up to Day 47)
- Cmax, plasma dFdC (Arm 2)(From Day 0 up to Day 47)
- Tmax, urine dFdC (Arm 1)(From Day 0 up to Day 32)
- Number of participants who are tolerant of TAR-200 indwelling (Arm 2)(From Day 21 up to Day 42)
- Tmax, plasma dFdC (Arm 2)(From Day 0 up to Day 47)
- Cmax, urine dFdU (Arm 2)(From Day 0 up to Day 47)
- Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 1)(Anti-tumor analysis will occur at the following study day visit Day 28)
- Tmax, plasma dFdU (Arm 2)(From Day 0 up to Day 47)
- Cavg, plasma dFdC (Arm 2)(From Day 0 up to Day 47)
- Cavg, urine dFdU (Arm 2)(From Day 0 up to Day 47)
- Cmax, urine dFdC (Arm 2)(From Day 0 up to Day 47)
- Tmax, urine dFdC (Arm 2)(From Day 0 up to Day 47)
- Cavg, urine dFdC (Arm 2)(From Day 0 up to Day 47)
- Preliminary anti-tumor effects will be assessed in tumor material (post-treatment) for assessment of immunohistochemical tissue biomarkers of drug-induced cell death (AKT, CD31, Ki67, TUNEL). (Arm 2)(Anti-tumor analysis will occur at the following study day visit Day 42)
- Tmax, urine dFdU (Arm 2)(From Day 0 up to Day 47)
研究者
研究点 (2)
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