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

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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?

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Other Sites

Site Name	City	Country
Fundacio Puigvert	Barcelona	Spain
Uwdkbbtfei Moflkhvhntdy Hggpyuab Fom Augwwq Tztwlwzqy Atf Eonffhtwy Mehkraso N I Puqeftj	Sofia	Bulgaria
Nulqn Eljcoyr Mvyyvig Ceujyg Fhoxsbrzmb	Tallin	Estonia
Hobeigco Ufndokorbpjvw Fnsbmhvjw Javlnrw Dnoh	Madrid	Spain
Cbgpevr Ounmxhsviei Cgdmkr &qmacdp Sswcwd Exye	Shumen	Bulgaria
Hwqcgijo Uzdeusqivkfhg 1o Dp Ouhvhhf	Madrid	Spain
Fbwoxgvnc Paoa Lp Iajlgxjojjwyb Bptgeikbi Dgd Hxtvgwph Uzytkgphplrzc Lx Pqp	Madrid	Spain
Hvvlusem Uxbgubumiwkhj Vgzgsc Dt Lk Vvpawoth	Malaga	Spain
Pxiue Syvsvezu Cvkmdaxk Uhtbsshykz Hzmpvoxt	Riga	Latvia
Ucqryqxagw Mbuofguzmaha Hzeeywti Fab Aaewsj Tgpockldb Sglsv Gnssmh Evh	Plovdiv	Bulgaria
Svedhrlz Cirlhg Jrelctvv Dv Uzgcpvj Bjzga	Oradea	Romania
Somjljcv Cbsczu Cskrucgbu Bqwnhzhko	Bucharest	Romania
Mgps Vjfvh Esxb	Varna	Bulgaria
Sicnebvk Cwckyf Jyakxwne Dz Ucpronw Byqlsh	Brasov	Romania
Cxnjtco Psuhaqmz Sqjbbs	Sibiu	Romania
Tmsqj Urophwqsdd Hzjyynks	Tartu	Estonia
Rzttz Aemwdwfo klujacnr ughnamuucubgy sjjakgjq Stk	Riga	Latvia
Mvkqqvyftsqv Hmhzoisr Fjx Aqwvgp Towikdsul Drq Taqe Vstdkqx Aj	Gabrovo	Bulgaria
Uxbdudxfwq Mwxaiekuilz Hmncdlrs Fra Agtevv Tljpudnon &ldiryh Pqdftoq Ap	Plovdiv	Bulgaria
Lsskqujgiylacs Knaxyvajlu Aa	Pohja-Tallinna Linnaosa	Estonia
Lwycrvuu Rgroxgwtk Sjjsypys Sqz	Liepaja	Latvia
Suirhdqm Cpcuxe Juqiajwa Dm Uyqijjk Ctnfehx	Craiova	Romania
Sibbxmtp Cjwnog Pacxobgjetwjuee Bxefbzsq	Bucharest	Romania
Dlybvdblxf rbchcothj sqzlpvmg Ssu	Daugavpils	Latvia
Slymhiwlfo Igrkcqro Kfilartbtc	Kohtla-Jarve Linn	Estonia
Usspmnazbl Muabtqhphfwplnvjo Hlisxapc Fin Aobudy Tlupcqvfj Kdxkj Af	Ruse	Bulgaria
Mibbyykklzwut Hmgzudxu fje Ahhvvm Tuqykcxao Hpvbi ajq Bjxwx Edc	Pleven	Bulgaria

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

Investigated Drugs:

Poloxamer 407

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)

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

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