NL-OMON46772已完成不适用
A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects with Muscle-Invasive Transitional Cell Carcinoma of the Bladder - Phase 1b Safety and Tolerability Study of GemRIS in MIBC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological proof of muscle-invasive transitional cell carcinoma of the bladder (clinical stage T2a-T3b). Subjects with evidence of metastatic nodal disease to the obturator or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of fixation of the pelvic sidewall are not eligible.
- •2. In Arm 1, subjects must have residual visible tumor following TURBT. In Arm 2, subjects must be fully resected (i.e., no visible tumor or as little tumor as is possible) after restaging TURBT within 6 weeks prior to Study Day 0.
- •3. Adequate bone marrow, liver, and renal function, as assessed by the following requirements conducted within 21 days prior to dosing:
- •a) Hemoglobin *9.0 g/dL
- •b) Absolute neutrophil count (ANC) *1,500/mm3
- •c) Platelet count *100,000/mm3
- •d) Total bilirubin *1.5xULN (upper limit of normal)
- •e) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) *2.5xULN
- •f) Glomerular Filtration Rate (GFR) *30% (*30 ml/min/1.73 m2)
- •4. Subjects must be willing to undergo a cystoscopy on study for investigational product insertion and removal.
- •5. Eligible for and willing to undergo radical cystectomy per the attending urologist.
- •6. Subjects must refuse neoadjuvant cisplatin-based combination chemotherapy (and understand the risks and benefits of doing so) or be deemed ineligible for cisplatin-based combination chemotherapy by the attending medical oncologist.
- •7. Prior radiation therapy is allowed provided that no radiation therapy was administered to the urinary bladder.
- •8. Written informed consent and authorization for release of personal health information obtained according to local laws.
- •9. Age *18 years at the time of consent.
- •10. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject*s partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
- •11. Males must be willing to use an effective method of contraception/method to avoid seminal transfer (barrier method or abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Subject*s partner must also use barrier protection while subject is on study until 4 weeks after treatment discontinuation.
- •12. Females of childbearing potential must have a negative pregnancy test within 21 days prior to Study Day 0.
排除标准
- •1. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- •2. Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other prior systemic chemotherapy for a non-urothelial carcinoma must have been completed >5 years prior to initiation of study.
- •3. Previous exposure to gemcitabine instillations.
- •4. Currently receiving other intravesical chemotherapy.
- •5. Concurrent clinically significant infections as determined by the treating investigator.
- •6. Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of GemRIS.
- •7. Documented history of vesicoureteral reflux or the presence of an indwelling ureteral stent or nephrostomy tube at the time of screening.
- •8. Evidence of bladder perforation during diagnostic cystoscopy.
- •9. Pelvic radiotherapy administered within less than 6 months prior to enrollment. Subjects who received radiotherapy *6 months prior to enrollment must demonstrate no cystoscopic evidence or symptoms of radiation cystitis.
- •10. Bladder Post-Void Residual Volume (PVR) of >250 mL.
- •11. Known hypersensitivity to gemcitabine or chemically-related drugs.
- •12. Known hypersensitivity to the drug constituent, device constituent or TARIS Inserter materials.
- •13. Active, uncontrolled urogenital bacterial, viral or fungal infections, including urinary tract infection that, in the opinion of the investigator, contraindicates participation. Skin/nail fungal infections are not exclusionary. Subjects with active shingles (varicella zoster infection) will be excluded from the study.
- •14. Use of an investigational product within 30 days or 5 half-lives, whichever is longer, preceding Study Day 0.
- •15. 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.
- •16. History of diagnosis of neurogenic bladder.
- •17. Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors, within 2 weeks of Study Day 0, exclusive of steroid doses *5 mg daily.
- •18. History of any of the following within 3 months prior to Screening Visit:
- •- Major illness/major surgery (requiring hospitalization), including pelvic, lower back surgery or procedure unrelated to bladder cancer; most outpatient procedures are not exclusionary
- •- Renal or ureteral stone disease or instrumentation
- •- Childbirth
- •19. 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.
- •20. Difficulty providing blood samples.
- •21. 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.
- •22. Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.
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