Study on UGN-103 (Mitomycin) for Treating Low Grade Nonmuscle Invasive Bladder Cancer in Patients at Intermediate Risk of Recurrence

1 1 1

What is this study about?

This clinical trial is focused on studying a type of bladder cancer known as Nonmuscle Invasive Bladder Cancer (NMIBC). This form of cancer affects the bladder but does not invade the muscle layer. The study is specifically looking at patients with low-grade NMIBC who are at an intermediate risk of the cancer coming back. The treatment being tested is called UGN-103, which is a new formulation of a drug known as Mitomycin. This treatment is administered directly into the bladder in the form of a solution.

The purpose of the study is to evaluate how effective and safe UGN-103 is in treating this type of bladder cancer. Participants in the study will receive the treatment and will be monitored over a period of time to see how well the cancer responds. The study will involve regular check-ups, including procedures like cystoscopy, which is a way to look inside the bladder, and urine tests to check for cancer cells. The study will also track any side effects or reactions to the treatment to ensure it is safe for patients.

Throughout the study, the main goal is to see if the treatment can successfully remove the cancer and prevent it from returning. Participants will be followed for several months to observe the long-term effects of the treatment. This research aims to provide new insights into treating Nonmuscle Invasive Bladder Cancer and potentially offer a new option for patients with this condition.

1 joining the study

Upon joining the study, the patient will be required to provide written informed consent. This consent confirms understanding and agreement to comply with the study requirements.

The patient must be at least 18 years old and have a confirmed diagnosis of low-grade nonmuscle invasive bladder cancer (LG NMIBC) through a biopsy.

2 screening and eligibility confirmation

The patient will undergo a screening process to confirm eligibility. This includes verifying a history of at least one prior episode of nonmuscle invasive bladder cancer and ensuring the disease is of intermediate risk.

Laboratory tests will be conducted to ensure adequate organ and bone marrow function. These tests include checking white blood cell count, platelet count, and kidney function, among others.

3 treatment administration

The treatment involves the administration of UGN-103, a formulation of Mitomycin, delivered directly into the bladder (intravesical use).

The medication is provided as a powder that is mixed into a solution for administration. The specific dosage and frequency will be determined by the study protocol.

4 monitoring and follow-up

The patient will be monitored regularly to assess the treatment’s effectiveness and safety. This includes cystoscopy, urine tests, and possibly biopsies to evaluate the response to treatment.

The primary goal is to determine the complete response rate (CRR) at the three-month visit after the first treatment.

5 evaluation of treatment outcomes

Secondary evaluations will include the duration of response and monitoring for any adverse effects. This involves regular clinical assessments and laboratory tests.

Exploratory assessments may include changes in quality of life scores and analysis of biomarkers in tumor tissue.

Who Can Join the Study?

Provide written informed consent, which means you agree to follow the study’s rules and understand what the study involves.
You must be 18 years of age or older.
You must have a type of bladder cancer called Nonmuscle Invasive Bladder Cancer (NMIBC), confirmed by a specific type of biopsy within 8 weeks before the study starts. This biopsy checks the tumor’s characteristics, but the tumor should not be removed during this process.
You must have had at least one previous episode of NMIBC before the current one being studied.
You should have intermediate risk disease, which means you have one or two of the following: multiple tumors, a single tumor larger than 3 cm, or a recurrence of NMIBC within one year of the current diagnosis. If you have all three, you are considered high risk and cannot participate.
You must have a negative result for high-grade disease in a test called voiding cytology within 8 weeks before the study.
Your organs and bone marrow must be functioning well, as shown by routine blood tests. These tests check things like white blood cells, platelets, and kidney function.
You should have a life expectancy that covers the duration of the trial.
Both male and female participants must use effective birth control methods during the study and for 6 months after treatment if they or their partners can have children. This includes methods like implants, injections, certain birth control pills, hormonal intrauterine devices, condoms with spermicide, or complete sexual abstinence. Periodic abstinence is not acceptable.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Hospital Universitario 12 De Octubre	Madrid	Spain
Spitalul Clinic Judetean De Urgenta Craiova	Craiova	Romania
Spitalul Clinic Prof.Dr.Theodor Burghele	Bucharest	Romania
Daugavpils regionala slimnica SIA	Daugavpils	Latvia
Sihtasutus Ida-Viru Keskhaigla	Kohtla-Jarve Linn	Estonia
University Multiprofessional Hospital For Active Treatment Kanev AD	Ruse	Bulgaria
Fundacio Puigvert	Barcelona	Spain
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Spitalul Clinic Judetean De Urgenta Bihor	Oradea	Romania
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania
Tartu University Hospital	Tartu	Estonia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD	Gabrovo	Bulgaria
University Multiprophy Hospital For Active Treatment – Plovdiv AD	Plovdiv	Bulgaria
Laane-Tallinna Keskhaigla AS	Pohja-Tallinna Linnaosa	Estonia
Complex Oncological Center – Shumen EOOD	Shumen	Bulgaria
Liepajas Regionala Slimnica SIA	Liepaja	Latvia
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
North Estonia Medical Centre Foundation	Tallin	Estonia
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Cpxbfqn Pqoidzlz Swndgk	Sibiu	Romania
Meek Vokbf Elgx	Varna	Bulgaria
Sissrnwi Cptvdt Jqcoxxpt Dc Umfnltl Bgrqps	Brasov	Romania
Rctkx Arwcsiqa kpvrkwtn uixulxjaryxgv shmcybvk Ssq	Riga	Latvia
Fgubvpqbf Plus Lt Itoignuowhpsp Btwxfvhcy Ddz Hshgaict Urwwhwdbxhleq Lm Pkg	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.10.2024
Estonia	Not recruiting	01.10.2024
Latvia	Not recruiting	01.10.2024
Romania	Not recruiting	01.10.2024
Spain	Not recruiting	01.10.2024

Trial locations

UGN-103 is a new formulation of a medication called UGN-102. It is being studied for its ability to treat patients with a type of bladder cancer known as low-grade nonmuscle invasive bladder cancer. This medication is designed to help remove or reduce tumors in patients who are at an intermediate risk of the cancer coming back.

Investigated diseases:

Bladder cancer

Nonmuscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not spread into the muscle layer. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. The disease progresses as the cancer cells grow and may form tumors on the bladder wall. Over time, if untreated, these tumors can become larger and potentially invade deeper layers of the bladder or spread to other parts of the body. The progression is typically monitored through regular cystoscopy and urine tests to detect any changes in the bladder lining.

Trial ID:

2023-507261-25-00

Protocol code:

BL013

NCT ID:

NCT06331299

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on UGN-103 (Mitomycin) for Treating Low Grade Nonmuscle Invasive Bladder Cancer in Patients at Intermediate Risk of Recurrence

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?