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This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intravesically in participants with NMIBC. Both intermediate risk and BCG-unresponsive NMIBC participants will be included.
The Phase 1/1b study consist of two parts: Dose Escalation and Dose Expansion. In the Dose Escalation Part, E7766 will be administered intravesically to participants with intermediate risk NMIBC or participants with BCG unresponsive NMIBC with increased dose levels to assess safety/tolerability profile of E7766 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7766. In the Dose Expansion Part, E7766 at RP2D will be administered to participants with NMIBC with or without carcinoma in situ (CIS) to confirm safety and assess preliminary clinical activity of E7766 as a single agent. Clinical activity will be evaluated by complete response (CR) rates at 3 months, 6 months, 12 months, 18 months, 24 months, and by duration of complete response (DOCR) in all participants who have achieved CR on treatment with E7766.
Not yet recruiting
Published on BioPortfolio: 2019-10-04T08:31:41-0400
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants ...
This project focuses on developing specific and sensitive detectors of biomarker-based signatures associated with diagnosed and recurrent bladder cancer.
Risk factors for bladder injury during Cesarean Section are well known. Most of cases of bladder injury occur in presence of previous Cesarean Sections, morbidly adherent placenta, or prev...
This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.
To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.
A 66-year-old woman was referred to our hospital because a bladder tumor was detected by abdominal ultrasonography. Although she was asymptomatic, cystoscopy showed the nodular sessile tumor in the bl...
Non-traumatic urinary bladder emergencies are rare but critical diagnoses to make in an emergency setting. Acute urinary bladder pathologies require an accurate and timely diagnosis to ensure a favora...
As a rare bladder tumor, paraganglioma of the urinary bladder (PUB) is frequently misdiagnosed as bladder cancer, particularly for the non-functional type. To date, transurethral resection remains a c...
To investigate surgical approaches to urinary incontinence and long-term continence outcomes after successful bladder reconstruction in a heterogeneous patient population with classic bladder exstroph...
Epidermoid cyst of the bladder is a very rarely encountered benign lesion. Up to our knowledge, we present the second case of epidermoid cyst of the urinary bladder in literature. We report a case of ...
Tumors or cancer of the URINARY BLADDER.
A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.
Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.
An abnormal passage in the URINARY BLADDER or between the bladder and any surrounding organ.
Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Non-invasive bladder cancer is a cancer that is only in the inner lining of the bladder. Invasive bladder cancer is cancer that has spread into the deeper walls of the bladder. When the cancer has spread outside the bladder to other parts of the body, th...