Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02773849
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2016-04-19
Brief Title:
ADSTILADRIN INSTILADRIN in Patients With High-Grade Bacillus Calmette-Guerin BCG Unresponsive Non-Muscle Invasive Bladder Cancer NMIBC
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Phase III Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN rAd-IFNSyn3 Administered Intravesically to Patients With High-Grade BCG Unresponsive Non-Muscle Invasive Bladder Cancer NMIBC
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are BCG Unresponsive which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG
Detailed Description:
Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in Non-Muscle Invasive Bladder Cancer NMIBC ADSTILADRIN is a non-replicating adenovirus vector harboring the human IFN alpha2b gene When combined with the excipient Syn3 intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein Clinical studies have confirmed that IFN alpha2b protein can be measured in the urine of patients treated with ADSTILADRIN within 24 hours after dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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