Your session is about to expire
← Back to Search
Other
UGN-201 for Bladder Cancer
Phase 1
Waitlist Available
Led By Neema Navai
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is studying the safety of a drug called UGN-201 in people with bladder cancer who are having surgery. The side effects of the drug and any complications from surgery will be monitored. The study will also look at how well the drug works in downgrading the cancer and at changes in biomarkers in response to the drug.
Who is the study for?
Adults with bladder cancer who are set for radical cystectomy, have ECOG Performance Status of 0 or 1, and no stage 3 disease or higher. They must not be on immunosuppressants, have a history of certain cancers within the last two years, active infections that need systemic treatment, or known hypersensitivity to UGN-201. Women of childbearing potential must test negative for pregnancy.Check my eligibility
What is being tested?
The trial is testing UGN-201's safety in patients with urothelial carcinoma undergoing surgery. It monitors toxicity until 30 days post-surgery or if it delays surgery over 12 weeks. The study also explores how well UGN-201 works by checking if the cancer has been down-staged after treatment.See study design
What are the potential side effects?
Possible side effects include surgical complications related to the drug that could delay surgery beyond three months from decision date, any severe toxicities possibly linked to UGN-201 leading up to a month after dosing, and potentially death related to treatment toxicity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To establish the safety profile of UGN-201 in patients with urothelial carcinoma undergoing radical cystectomy.
Side effects data
From 2007 Phase 4 trial • 551 Patients • NCT0011664930%
Actinic Keratosis
23%
Application site pruritus
15%
Basal cell carcinoma
15%
Squamous cell carcinoma
11%
Skin lesion
9%
Application site irritation
8%
Seborrhoeic Keratosis
6%
Skin Papilloma
6%
Fatigue
5%
Application site pain
5%
Upper respiratory tract infection
1%
Myocardial infarction
1%
Coronary artery disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aldara (Imiquimod) Cream
Trial Design
1Treatment groups
Experimental Treatment
Group I: UGN-201 Pre Radical CystectomyExperimental Treatment1 Intervention
UGN-201 200 mg/50ml
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,981 Previous Clinical Trials
1,789,711 Total Patients Enrolled
Neema NavaiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking or have recently taken a medication or used a medical device that is still being tested in studies.You have advanced or metastatic bladder cancer, or certain uncommon types of bladder cancer.You have a condition that weakens your immune system, or you are taking medications that weaken your immune system.You have had tuberculosis (TB) in the past.You have had trouble peeing recently.You have a urethral stricture that would make it difficult to use a urinary catheter.You have had radiation treatment in the pelvic area.You have a history of problems with your bladder caused by nerve damage.You have a medical condition that makes it difficult for you to urinate normally.You have been treated with a specific type of medication that affects the immune system.You have been diagnosed with HIV.You have a current, active infection of Hepatitis B or Hepatitis C.You have received treatment for bladder cancer with medications that travel throughout your body. If you have cT3 or larger urothelial carcinoma of the bladder, you can still participate.You are able to carry out all your normal activities without any limitations, or with only slight limitations.You have an autoimmune disease that needed strong medication in the past 2 years.You have a history of lung inflammation that is not caused by an infection.You have been diagnosed with urothelial cancer and it has not spread beyond stage 2.Your organs need to work well, and your recent test results need to show that.You are allergic to UGN-201 or any of its ingredients.You have been diagnosed with any other type of cancer, except for certain types of skin cancer or non-invasive cervical cancer, within the past 2 years.You have cancer that has spread to other parts of your body, as confirmed by standard tests.You have a serious ongoing infection that needs medicine to be treated, and it cannot be resolved before starting the study treatment.You don't have cancer that has spread to other parts of your body, and your doctor thinks you are suitable for surgery.Women who could become pregnant must have a negative pregnancy test before starting the study. If the urine test shows a positive result or cannot confirm a negative result, a blood test will be needed.
Research Study Groups:
This trial has the following groups:- Group 1: UGN-201 Pre Radical Cystectomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What previous experiments have utilized UGN-201 as a primary focus?
"Presently, 21 clinical trials are being held for the investigation of UGN-201. Out of those active studies, 5 have entered Phase 3 and 84 distinct locations across America are participating in these experiments. Notably, most of these sites can be found near Houston, Texas."
Answered by AI
Are there any available openings in this clinical experiment for participants?
"The pertinent clinical trial is actively enrolling participants, with its inception having taken place on January 24th 2022 and the latest update being applied July 11th 2022."
Answered by AI
How many participants are involved in the research project?
"Affirmative, the information found on clinicaltrials.gov specifies that this trial is actively seeking participants. It was initially posted January 24th 2022 and was last updated July 11th 2022. The study requires a total of 10 patients at one medical centre."
Answered by AI
Has the FDA greenlit UGN-201 for commercialization?
"The lack of substantial clinical data surrounding UGN-201's safety and efficacy lead to its score being 1 on the scale."
Answered by AI
What indications is UGN-201 prescribed for?
"UGN-201 is mainly used to treat issues concerning the scalp. It may also be prescribed for those suffering from condylomata acuminata, facial disorders, and superficial basal cell carcinoma."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger