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临床试验/EUCTR2021-005948-29-AT
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

发起方
roGen Pharma Ltd.

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