Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01687244
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2012-09-06
Brief Title:
Intravesical Administration of rAd-IFNSyn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer
Sponsor:
FKD Therapies Oy
Organization:
FKD Therapies Oy
Study Overview
Official Title:
A Phase 2 Randomized Open Label Parallel Arm Study to Evaluate the Safety and Efficacy of rAd-IFNSyn3 Following Intravesical Administration in Subjects With High Grade BCG Refractory or Relapsed Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN rAd-IFN with Syn3 when given intravesically to patients with high grade non-muscle invasive bladder cancer who are refractory to or have relapsed from BCG therapy The pharmacodynamics of INSTILADRIN will also be studied by measuring the interferon IFNα2b levels excreted in the urine rAd-IFN is a non-replicating recombinant adenovirus type 5 Ad5-vector encoding the interferon alpha-2b IFNα2b gene Syn 3 is clinical surfactant excipient which enhances the ability of the adenoviral vector to transfect cells in the bladder wall
Detailed Description:
Criteria for Evaluation
Efficacy A Response is defined as no evidence of recurrence of a high grade tumor by cystoscopy cytology or if clinically indicated biopsy
Safety The safety and tolerability of INSTILADRIN will be evaluated based on adverse event reports vital signs ECGs clinical laboratory values and results of physical examination
Efficacy A Response is defined as no evidence of recurrence of a high grade tumor by cystoscopy cytology or if clinically indicated biopsy
Safety The safety and tolerability of INSTILADRIN will be evaluated based on adverse event reports vital signs ECGs clinical laboratory values and results of physical examination
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