Trial Outcomes & Findings for Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) (NCT NCT05136898)
NCT ID: NCT05136898
Last Updated: 2024-09-19
Results Overview
The number of patients with each type of event will be summarized. TEAEs were defined as adverse events (AEs) that occurred on or after the day of the first instillation of UGN-102 or pre-treatment AEs that worsened during the study.
COMPLETED
PHASE3
8 participants
Up to 3 months
2024-09-19
Participant Flow
Participant milestones
| Measure |
UGN-102
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
UGN-102
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
Baseline characteristics by cohort
| Measure |
UGN-102
n=8 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
|
Previous Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) Episode(s)
Yes
|
8 Participants
n=5 Participants
|
|
Previous Low-grade (LG) Non-muscle Invasive Bladder Cancer (NMIBC) Episode(s)
No
|
0 Participants
n=5 Participants
|
|
Previous LG-NMIBC Episode(s) Within 1 Year
Yes
|
6 Participants
n=5 Participants
|
|
Previous LG-NMIBC Episode(s) Within 1 Year
No
|
2 Participants
n=5 Participants
|
|
Prior Transurethral Resection of Bladder Tumor (TURBT)
Yes
|
8 Participants
n=5 Participants
|
|
Prior Transurethral Resection of Bladder Tumor (TURBT)
No
|
0 Participants
n=5 Participants
|
|
Tumor Burden
≤ 3 cm
|
4 Participants
n=5 Participants
|
|
Tumor Burden
> 3 cm
|
4 Participants
n=5 Participants
|
|
Tumor Count
Single
|
3 Participants
n=5 Participants
|
|
Tumor Count
Multiple
|
5 Participants
n=5 Participants
|
|
Smoking History
Yes
|
5 Participants
n=5 Participants
|
|
Smoking History
No
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: All patients who received any dose of UGN-102.
The number of patients with each type of event will be summarized. TEAEs were defined as adverse events (AEs) that occurred on or after the day of the first instillation of UGN-102 or pre-treatment AEs that worsened during the study.
Outcome measures
| Measure |
UGN-102
n=8 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.
Any serious TEAEs
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.
Any TEAEs leading to discontinuation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.
Any TEAEs of special interest
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation, and TEAEs of Special Interest.
Any TEAEs
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: All patients who received any dose of UGN-102 and who had a post-baseline laboratory value.
PCS laboratory criteria were defined for the following parameters: Hematology * Hemoglobin \< 0.8 × lower limit of normal and \> 20% decrease from baseline or \> 1.3 × upper limit of normal (ULN) and \> 30% increase from baseline. * Leukocytes ≤ 2.8 or ≥ 16 × 10\^3/µL. * Lymphocytes \< 0.5 or \> 20 × 10\^3/µL. * Neutrophils \< 1.0 × 10\^3/µL. * Platelets \< 75 or ≥ 700 × 10\^3/µL. Chemistry * Creatinine \> 2.2 mg/dL. * Sodium ≤ 130 or \> 150 mEq/L. * Potassium \< 3.0 or \> 5.5 mEq/L. * Total bilirubin \> 1.5 × ULN. * Alanine aminotransferase (ALT) \> 3 × ULN. * Aspartate aminotransferase (AST) \> 3 × ULN. * Gamma glutamyl transferase \> 2.5 × ULN.
Outcome measures
| Measure |
UGN-102
n=8 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values
Hematology
|
0 Participants
|
|
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values
Chemistry
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: All patients who received any dose of UGN-102.
Patients were asked to rate their experience receiving UGN-102 at home after each instillation was completed. A total of 5 domains (8 questions) were assessed: * Comfort (3 questions, possible range from 3 "least favorable" to 12 "most favorable"). * Safety/concerns (1 question, possible range from 1 "least favorable" to 4 "most favorable"). * Communication (2 questions, possible range from 2 "least favorable" to 8 "most favorable"). * Preference compared to office instillation (1 question, possible range from 1 "least favorable" to 4 "most favorable"). * Overall experience/satisfaction (1 question, possible range from 1 "least favorable" to 4 "most favorable"). A composite score (sum of all 8 question scores) was also calculated (possible range from 8 "least favorable" to 32 "most favorable").
Outcome measures
| Measure |
UGN-102
n=8 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Composite Score for the Post-instillation Patient Questionnaire
Post 3rd instillation
|
32 score on a scale
Interval 30.0 to 32.0
|
|
Composite Score for the Post-instillation Patient Questionnaire
Post 5th instillation
|
32 score on a scale
Interval 30.0 to 32.0
|
|
Composite Score for the Post-instillation Patient Questionnaire
Post 2nd instillation
|
32 score on a scale
Interval 26.0 to 32.0
|
|
Composite Score for the Post-instillation Patient Questionnaire
Post 4th instillation
|
32 score on a scale
Interval 30.0 to 32.0
|
|
Composite Score for the Post-instillation Patient Questionnaire
Post 6th instillation
|
32 score on a scale
Interval 29.0 to 32.0
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: All patients who received any dose of UGN-102.
Home health professionals (HHPs) were asked to share their experience administering UGN-102 at the patient's home after each instillation was completed. A total of 4 domains (4 questions) were assessed: * Comfort - Were you comfortable performing the instillation at this patient's home, yes (most favorable) or no (least favorable)? * Difficulty - Was it difficult to perform the instillation at this patient's home, yes (least favorable) or no (most favorable)? * Safety/concerns - Did you have any concerns performing the instillation in the home setting, yes (least favorable) or no (most favorable)? * Adequate support - Did you have sufficient support performing the instillation in the home setting, yes (most favorable) or no (least favorable)? The number of patients whose HHP had a "most favorable" response to all 4 questions is summarized for each home instillation.
Outcome measures
| Measure |
UGN-102
n=8 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Responses to the Post-instillation Home Health Professional Questionnaire
Post 5th instillation
|
7 Participants
|
|
Responses to the Post-instillation Home Health Professional Questionnaire
Post 6th instillation
|
5 Participants
|
|
Responses to the Post-instillation Home Health Professional Questionnaire
Post 2nd instillation
|
8 Participants
|
|
Responses to the Post-instillation Home Health Professional Questionnaire
Post 3rd instillation
|
7 Participants
|
|
Responses to the Post-instillation Home Health Professional Questionnaire
Post 4th instillation
|
7 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All patients who received any dose of UGN-102 and who completed the end of study questionnaire.
Patient recommendations regarding home instillation of UGN-102 were collected at the 3-month Visit or Early Termination Visit. Two questions were asked: * Will you recommend home instillations of UGN-102 for other patients with NMIBC, yes (most favorable) or no (least favorable)? * Will you recommend home instillations of UGN-102 instead of having transurethral resection of bladder tumor (TURBT) for other patients with NMIBC, yes (most favorable) or no (least favorable)? The number of patients who had a "most favorable" response is summarized by question. In addition, investigators were asked if the experience of having their patient receive instillations at home was less difficult (most favorable), more difficult (least favorable), or not different than having them receive instillations in the office. All responses are summarized.
Outcome measures
| Measure |
UGN-102
n=6 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Responses to End of Study Patient and Investigator Questionnaires
Recommend home instillations of UGN-102 instead of having TURBT = yes
|
5 Participants
|
|
Responses to End of Study Patient and Investigator Questionnaires
Having patient receive instillations at home is less difficult than in office
|
0 Participants
|
|
Responses to End of Study Patient and Investigator Questionnaires
Having patient receive instillations at home is more difficult than in office
|
1 Participants
|
|
Responses to End of Study Patient and Investigator Questionnaires
Having patient receive instillations at home is not different than in office
|
5 Participants
|
|
Responses to End of Study Patient and Investigator Questionnaires
Recommend home instillations of UGN-102 for other NMIBC patients = yes
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All patients who received any dose of UGN-102.
CRR is defined as the percentage of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions, if applicable, and voiding urine cytology.
Outcome measures
| Measure |
UGN-102
n=8 Participants
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Complete Response Rate (CRR)
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
Adverse Events
UGN-102
Serious adverse events
| Measure |
UGN-102
n=8 participants at risk
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Nervous system disorders
Embolic stroke
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Nervous system disorders
Intracranial aneurysm
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
Other adverse events
| Measure |
UGN-102
n=8 participants at risk
6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
|
|---|---|
|
Renal and urinary disorders
Dysuria
|
25.0%
2/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
General disorders
Fatigue
|
25.0%
2/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Renal and urinary disorders
Hypertonic bladder
|
25.0%
2/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Cardiac disorders
Atrial flutter
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Nervous system disorders
Carotid artery stenosis
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Psychiatric disorders
Delirium
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Renal and urinary disorders
Micturition urgency
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
|
Renal and urinary disorders
Urine flow decreased
|
12.5%
1/8 • Up to 3 months
Per protocol, sites were instructed to report AEs that occurred from the time of informed consent to the 3-month Visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place