Bladder Cancer Clinical Trial
— OPTIMA IIOfficial 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
Verified date | September 2022 |
Source | UroGen Pharma Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 63 |
Est. completion date | October 21, 2020 |
Est. primary completion date | January 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Willing and able to sign an informed consent and comply with the protocol. 2. Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening. 3. Is at intermediate risk of recurrence, defined as having 1 or 2 of the following: - Presence of multiple tumors; - Solitary tumor > 3 cm; - Recurrence (= 1 occurrence of LG NMIBC within 1 year of the current diagnosis). 4. Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of enrollment. 5. Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the participant is female or the female partner of a male participant and is of childbearing potential (defined as premenopausal women who have not been sterilized). 6. Has adequate organ and bone marrow function as determined by routine laboratory tests as below: - Leukocytes = 3,000 per µL; - Absolute neutrophil count = 1,500 per µL; - Platelets = 100,000 per µL; - Hemoglobin = 9.0 g/dL; - Total bilirubin = 1.5 x upper limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; - Alkaline phosphatase = 2.5 × ULN; - Estimated glomerular filtration rate (eGFR) = 30 mL/min. 7. Has no evidence of active urinary tract infection (UTI) at Screening and Baseline visits. - In the case of symptomatic UTI, the patient will be treated with a full course of antibiotics, and study drug will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of study drug is left to the discretion of the Principal Investigator (PI). Exclusion Criteria: 1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment. 2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 2 years. 3. History of HG papillary UC in the past 2 years. 4. Known allergy or sensitivity to mitomycin. 5. Clinically significant urethral stricture that would preclude passage of a urethral catheter. 6. History of pelvic radiotherapy. 7. History of: - Neurogenic bladder; - Active urinary retention; - Any other condition that would prohibit normal voiding. 8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC). 9. Has participated in a study with an investigational agent or device within 30 days of enrollment. 10. History of prior treatment with an intravesical chemotherapeutic agent with the exception of a single dose of chemotherapy immediately after any previous transurethral resection of bladder tumors (TURBT). 11. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol. |
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa | |
Israel | Rabin Medical Center | Petah tikva | |
United States | John Hopkins University | Baltimore | Maryland |
United States | The University of North Carolina | Chapel Hill | North Carolina |
United States | Urology San Antonio | Fredericksburg | Texas |
United States | Penn State Hershey State College | Hershey | Pennsylvania |
United States | Urology Las Vegas | Las Vegas | Nevada |
United States | Arkansas Urology | Little Rock | Arkansas |
United States | Loma Linda University | Loma Linda | California |
United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
United States | Urology Associates, PC | Nashville | Tennessee |
United States | Manhattan Medical Research | New York | New York |
United States | Montefiore Medical Center (Albert Einstein) | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | Western New York Urology Associates | New York | New York |
United States | Adult & Pediatric Urology, PC | Omaha | Nebraska |
United States | Mayo Clinic Cancer Center | Phoenix | Arizona |
United States | Clinical Research Center of Florida | Pompano Beach | Florida |
United States | Providence Medical Institute | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
UroGen Pharma Ltd. |
United States, Israel,
Chevli KK, Shore ND, Trainer A, Smith AB, Saltzstein D, Ehrlich Y, Raman JD, Friedman B, D'Anna R, Morris D, Hu B, Tyson M, Sankin A, Kates M, Linehan J, Scherr D, Kester S, Verni M, Chamie K, Karsh L, Cinman A, Meads A, Lahiri S, Malinowski M, Gabai N, R — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mitomycin Plasma Concentrations | Mitomycin plasma concentrations were assessed in a subset of 6 patients treated with UGN-102 | 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102 | |
Other | Mitomycin Area Under the Plasma Concentration-time Curve (AUC) | Mitomycin AUC was assessed in a subset of 6 patients treated with UGN-102 | 0 (pre-instillation) to 6 hours after the first instillation of UGN-102 | |
Other | Mitomycin Maximum Plasma Concentration (Cmax) | Mitomycin Cmax was assessed in a subset of 6 patients treated with UGN-102 | 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102 | |
Primary | 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. | 3 months after the first instillation of UGN-102 | |
Secondary | 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. | 6, 9, and 12 months after the first instillation of UGN-102 | |
Secondary | 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). | Up to 12 months | |
Secondary | 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 | Up to 12 months | |
Secondary | 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 | Up to 12 months | |
Secondary | Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings | The number of patients with abnormal, CS physical examination findings post-baseline will be summarized | Up to 12 months | |
Secondary | 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 | Up to 12 months |
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