Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462488
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2007-04-17
Brief Title:
Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
Sponsor:
Sesen Bio Inc
Organization:
Sesen Bio Inc
Study Overview
Official Title:
Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Patients With Non-Invasive Urothelial Carcinoma in Situ CIS Previously Treated With Bacille Calmette-Guérin BCG
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 30mgdose 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None