This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
Eligible patients were treated with 6 once-weekly intravesical instillations of UGN-102. The ablative effect of UGN-102 was evaluated at the 3-month Visit, which occurred 5 weeks ± 1 week after the last weekly instillation (3 months after initiation of study drug). Response was determined based on visual evaluation by cystoscopy (appearance, number, and size of the lesions) and, if there were remaining lesions, by histopathology of the remaining lesions. Complete response (CR) was defined as having no detectable disease (NDD) and was assessed visually during cystoscopy and also by urine cytology. In the event that the investigator was not sure, and there was suspect tissue, a small biopsy was taken from the suspect tissue to confirm CR in addition to cystoscopy and urine cytology. Patients who achieved a CR continued to have monthly telephone contacts to document any adverse events (AEs) and changes in concomitant medications and were assessed at 6, 9, and 12 months after the first instillation of UGN-102 for evidence of disease recurrence. Patients who had a non-complete response (non-CR) discontinued the study and continued with standard of care according to their treating physician. Safety was determined based on a review of AEs, laboratory assessments, and physical examination findings.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Complete Response (CR) Rate for UGN-102 Treatment
To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC. CR rate was defined as the percentage of patients with no detectable disease (NDD) as determined by cystoscopy, for cause biopsy, and urine cytology.
Time frame: 3 months after the first instillation of UGN-102
Durable Complete Response (DCR) Rate
To evaluate the durability of response in patients with LG NMIBC who achieve CR. DCR rate was defined as the percentage of patients who maintained CR at the respective time point.
Time frame: 6, 9, and 12 months after the first instillation of UGN-102
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Study Drug or Procedure Related TEAEs, TEAEs by Maximum Severity, TEAEs Leading to Treatment Discontinuation, and Serious TEAEs.
The number of patients with each type of event will be summarized. Adverse event severity was graded according to Common Terminology Criteria for Adverse Events version 5.0 as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant), Grade 4 (life-threatening), Grade 5 (fatal).
Time frame: Up to 12 months
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values
The number of patients who met PCS criteria for chemistry or hematology parameters post-baseline will be summarized
Time frame: Up to 12 months
Number of Participants With Post-baseline PCS Vital Signs Values
The number of patients who met PCS criteria for vital signs parameters post-baseline will be summarized
Time frame: Up to 12 months
Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings
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Loma Linda University
Loma Linda, California, United States
Providence Medical Institute
Santa Monica, California, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
John Hopkins University
Baltimore, Maryland, United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, United States
Urology Las Vegas
Las Vegas, Nevada, United States
Manhattan Medical Research
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
...and 9 more locations
The number of patients with abnormal, CS physical examination findings post-baseline will be summarized
Time frame: Up to 12 months
Number of Participants With Post-baseline CS Urology-oriented Physical Examination Findings
The number of patients with abnormal, CS urology-oriented physical examination findings post-baseline will be summarized
Time frame: Up to 12 months