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The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).
A phase II study was performed to assess the efficacy and tolerability of intravesical Vicinium in patients with urothelial carcinoma in situ of the bladder. Bacillus Calmette-Guérin treatment had previously failed in all patients. A total of 46 patients were treated with Vicinium with half being administered 30mg/dose once per week for 6 weeks (cohort 1) and the other half (cohort 2) the same dose but administered once per week for 12 consecutive weeks. Disease assessments consisting of urine cytology, cystoscopy and, if indicated, biopsy were performed at 3 month intervals. Patients that were disease-free at the assessment time point were allowed to continue treatment in the maintenance phase which consisted of three weekly doses, followed by 9 weeks of no treatment. As long as the patient remained disease-free, treatment continued for a total of one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Schedule A - | Active Comparator | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy. If the subject had histologically confirmed disease that is stage \ |
|
| Treatment Schedule B | Active Comparator | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy. If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicinium | Drug | Intravesical administration of Vicinium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy | Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment | 12 or 13 weeks |
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Inclusion Criteria:
Disease Characteristics
Prior/Concurrent Therapy
Patient Characteristics
The patient must have adequate organ function, as defined by the clinical trial protocol
Other
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Chapman | Sesen Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeastern Research Group, Inc. | Tallahassee | Florida | 32308 | United States | ||
| Johns Hopkins Medical Institutions |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22998907 | Derived | Kowalski M, Guindon J, Brazas L, Moore C, Entwistle J, Cizeau J, Jewett MA, MacDonald GC. A phase II study of oportuzumab monatox: an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with bacillus Calmette-Guerin. J Urol. 2012 Nov;188(5):1712-8. doi: 10.1016/j.juro.2012.07.020. Epub 2012 Sep 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Schedule A - | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy. If the subject had histologically confirmed disease that is stage \ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baltimore |
| Maryland |
| 21287 |
| United States |
| Lawrenceville Urology | Lawrenceville | New Jersey | 08648 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oregon Urology Institute Research | Springfield | Oregon | 97477 | United States |
| Grand Strand Urology | Myrtle Beach | South Carolina | 29572 | United States |
| Corpus Christi Urology Group, LLP | Corpus Christi | Texas | 78404 | United States |
| Urology of Virginia | Newport News | Virginia | 23606 | United States |
| Andreou Research | Surrey | British Columbia | V3V 1N1 | Canada |
| Can-Med Clinical Research Inc. | Victoria | British Columbia | V8T 5G9 | Canada |
| The Male/Female Health and Research Centre, Royal Court Medical Centre | Barrie | Ontario | L4M 7G1 | Canada |
| Urology Resource Centre | Burlington | Ontario | L7S 1V2 | Canada |
| McMaster University, Institute of Urology at Saint Joseph's Hospital | Hamilton | Ontario | L8N 4A6 | Canada |
| Centre for Applied Urological Research | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| The Fe/Male Health Centre | Oakville | Ontario | L6H 3P1 | Canada |
| Todd Webster, M.D. | Owen Sound | Ontario | N4K 2J1 | Canada |
| The Scarborough Hospital | Scarborough Village | Ontario | M1P 2T7 | Canada |
| University of Toronto, Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| FG001 | Treatment Schedule B | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy. If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS). Vicinium: Intravesical administration of Vicinium |
| Completed Induction Phase |
|
| Completed Induction 2/Maintenance 1 |
|
| Completed Maintenance 2 |
|
| COMPLETED | Completed the full 51/57 weeks of study |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Schedule A - | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy. If the subject had histologically confirmed disease that is stage \ |
| BG001 | Treatment Schedule B | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy. If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS). Vicinium: Intravesical administration of Vicinium |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy | Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment | One subject in Treatment Schedule A was not evaluated for complete response after the induction phase as they were ineligible to be on trial and therefore discontinued after receiving one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of patients | 12 or 13 weeks |
|
|
|
60 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Schedule A - | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy. If the subject had histologically confirmed disease that is stage \ | 0 | 23 | 1 | 23 | 21 | 23 |
| EG001 | Treatment Schedule B | Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy. If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS). Vicinium: Intravesical administration of Vicinium | 0 | 23 | 5 | 23 | 22 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary retention | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Extravasation during TURBT | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) |
| ||
| Fatigue | General disorders | MedDRA (10.0) |
| ||
| Influenza like illness | General disorders | MedDRA (10.0) |
| ||
| Localized Oedema | General disorders | MedDRA (10.0) |
| ||
| Pyrexia | General disorders | MedDRA (10.0) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) |
| ||
| Urinary tract infection | Infections and infestations | MedDRA (10.0) |
| ||
| Blood urine present | Investigations | MedDRA (10.0) |
| ||
| Cells in urine | Investigations | MedDRA (10.0) |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
| ||
| Dizziness | Nervous system disorders | MedDRA (10.0) |
| ||
| Bladder pain | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Dysuria | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Haematuria | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Micturition urgency | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Nocturia | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Pollakiuria | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Urinary incontinence | Renal and urinary disorders | MedDRA (10.0) |
| ||
| Hypertension | Vascular disorders | MedDRA (10.0) |
| ||
| Hypotension | Vascular disorders | MedDRA (10.0) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachelle Dillon, Ph.D. | Sesen Bio | 204-452-7126 | 308 | rachelle.dillon@sesenbio.com |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C544997 | VB4-845 |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|