EUCTR2021-005948-29-AT招募中1 期
A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence - A Phase 3 Single-Arm Study of UGN-102 for Treatment of LG IR NMIBC
roGen Pharma Ltd.0 个研究点目标入组 220 人开始时间: 2022年6月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
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
- 性别
- All
入选标准
- •1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •2. Patient must be = 18 years of age at the time of signing the ICF.
- •3. Patient who has LG NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
- •4. History of LG NMIBC requiring treatment with TURBT. Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
- •5. Has intermediate risk disease, defined as having 1 or 2 of the following:
- •a. Presence of multiple tumors.
- •b. Solitary tumor > 3 cm.
- •c. Early or frequent recurrence (= 1 occurrence of LG NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
- •6. Negative voiding cytology for HG disease within 8 weeks before Screening.
- •7. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
- •Leukocytes = 3,000/µL (= 3 × 109/L).
- •Absolute neutrophil count = 1,500/µL (= 1.5 × 109/L).
- •Platelets = 100,000/µL (= 100 × 109/L).
- •Hemoglobin = 9.0 g/dL.
- •Total bilirubin = 1.5 × upper limit of normal (ULN).
- •Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) = 2.5 × ULN.
- •Alkaline phosphatase (ALP) = 2.5 × ULN.
- •Estimated glomerular filtration rate (eGFR) = 30 mL/min.
- •8. Has an anticipated life expectancy of at least the duration of the trial.
- •9. Both male and female patients:
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •a. Female partner of male patient:
- •Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the female partner is of childbearing potential (defined as premenopausal women who have not been sterilized).
- •Acceptable methods of birth control which are considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices
- •(only hormonal), condoms with spermicide, sexual abstinence* or vasectomized partner.
- •* Sexual abstinence is defined as refraining from intercourse from enrollment through 6 months post treatment. Periodic abstinence (calendar, symptothermal, postovulation methods) is NOT an acceptable method of contraception.
- •b. Female patient:
- •Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the patient is of childbearing potential (defined as
- •premenopausal women who have not been sterilized).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
排除标准
- •1. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
- •2. History of HG bladder cancer (papillary or carcinoma in situ [CIS]) in the past 2 years.
- •3. Known allergy or sensitivity to mitomycin that in the Investigator’s opinion cannot be readily managed.
- •4. Clinically significant urethral stricture that would preclude passage of a urethral catheter.
- •5. History of:
- •a. Neurogenic bladder.
- •b. Active urinary retention.
- •c. Any other condition that would prohibit normal voiding.
- •6. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC
- •7. Current tumor grading of T1
- •8. Concurrent upper tract urothelial carcinoma (UTUC).
- •9. Evidence of active urinary tract infection (UTI) that in the Investigator’s opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment.
- •10. Is pregnant or breastfeeding.
- •11. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the Investigator, the patient would be unable to comply with the protocol.
- •12. History of prior treatment with an intravesical chemotherapeutic agent in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT.
- •13. Has participated in a study with an investigational agent or device within 30 days of enrollment.
- •14. Has previously participated in a study in which they received UGN-102.
- •15. Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous
- •basal cell or squamous cell carcinomas that can be treated locally are allowed
- •16. Has any other clinically significant medical or surgical condition that in the Investigator’s opinion could compromise patient safety or the interpretation of study results
研究者
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