A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (OPTIMA II)
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|ClinicalTrials.gov Identifier: NCT03558503|
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : July 25, 2022
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Urothelial Carcinoma Urothelial Carcinoma Bladder||Drug: UGN-102||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence|
|Actual Study Start Date :||October 15, 2018|
|Actual Primary Completion Date :||January 3, 2020|
|Actual Study Completion Date :||October 21, 2020|
Patients were treated with 6 once-weekly intravesical instillations of UGN-102.
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).
Other Name: UGN-102 (mitomycin) for intravesical solution
- Complete Response (CR) Rate for UGN-102 Treatment [ Time Frame: 3 months after the first instillation of UGN-102 ]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.
- Durable Complete Response (DCR) Rate [ Time Frame: 6, 9, and 12 months after the first instillation of UGN-102 ]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.
- 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. [ Time Frame: Up to 12 months ]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).
- Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values [ Time Frame: Up to 12 months ]The number of patients who met PCS criteria for chemistry or hematology parameters post-baseline will be summarized
- Number of Participants With Post-baseline PCS Vital Signs Values [ Time Frame: Up to 12 months ]The number of patients who met PCS criteria for vital signs parameters post-baseline will be summarized
- Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings [ Time Frame: Up to 12 months ]The number of patients with abnormal, CS physical examination findings post-baseline will be summarized
- Number of Participants With Post-baseline CS Urology-oriented Physical Examination Findings [ Time Frame: Up to 12 months ]The number of patients with abnormal, CS urology-oriented physical examination findings post-baseline will be summarized
- Mitomycin Plasma Concentrations [ Time Frame: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102 ]Mitomycin plasma concentrations were assessed in a subset of 6 patients treated with UGN-102
- Mitomycin Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 0 (pre-instillation) to 6 hours after the first instillation of UGN-102 ]Mitomycin AUC was assessed in a subset of 6 patients treated with UGN-102
- Mitomycin Maximum Plasma Concentration (Cmax) [ Time Frame: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102 ]Mitomycin Cmax was assessed in a subset of 6 patients treated with UGN-102
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558503
|Study Director:||Elyse Seltzer, MD||UroGen Pharma|