A Phase III Study for Modification of Photodynamic Diagnosis of SPP-005 in Patients with Non-muscle Invasive Bladder Cancer (NMIBC) during Transurethral Resection of Bladder Tumor (TURBT)

Yamauchi Mitsugu0 个研究点目标入组 106 人开始时间: 2021年12月3日最近更新: 2023年10月17日

试验速览

暂无简介。

•1)Patients who are eligible for TURBT
•2)Patients who understand the informed consent document and can provide a written consent of their own free will
•3)Patients who are between 20 and 85 years old (at the time of signing the informed consent document)
•4)Patients with an ECOG Performance Status (ECOG PS) of 0 to 1 as determined at the time of enrollment
•5)Patients whose clinical laboratory values meet the following criteria (laboratory tests within 28 days prior to IMP administration)
•[Renal function]
•Serum creatinine: Less than 1.5 times the upper limit of the institutional standard
•[Hepatic function]
•AST (GOT): Less than 1.5 times the upper limit of the institutional standard
•ALT (GPT): Less than 1.5 times the upper limit of the institutional standard
•Serum bilirubin: Less than 1.5 times the upper limit of the institutional standard
•Platelet count:100,000/mm3 or more
•6)Patients who are able to comply with the requirements of the study protocol, including the schedule of visit days
•7)Patients suspected of having NMIBC, whether primary or recurrent, and in case of recurrence parents, at least 90 days have passed since the last day of the bladder cancer treatment.

•1)Patients with a history of or complications from any of the following
•-Myocardial infarction
•-Congestive heart failure
•-Angina pectoris requiring treatment
•-Arrhythmia requiring treatment
•2)Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, poorly controlled hypertension, diabetes mellitus, etc.)
•3)Patients with serious infectious diseases (including active tuberculosis)
•4)Patients with active multiple cancers
•5)Patients with systolic blood pressure of 100 mmHg or less, or diastolic blood pressure of 60 mmHg or less on the screening examination
•6)Patients with a history of hypotension during previous TURBT
•7)Female patients who are pregnant, lactating, or may be pregnant
•8)Patients who do not intend to use contraception*
•9)Patients with hypersensitivity or a history of hypersensitivity to porphyrin analogs.
•10)Patients who have received any investigational medical product (including study drugs in post-marketing clinical studies) within 90 days prior to the start of screening examination
•11)Patients who are scheduled to participate in clinical trials, etc. during the clinical trial period
•12)Other patients who are judged to be inappropriate by the principal or sub investigators.
•* Examples of contraception methods: condom, intrauterine device (IUD) and oral contraceptives (if a female participant use an oral contraceptive, a barrier method must be used concurrently).

发起方

Yamauchi Mitsugu