Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01687244
Study type Interventional
Source FKD Therapies Oy
Contact
Status Completed
Phase Phase 2
Start date September 2012
Completion date January 2016

See also
  Status Clinical Trial Phase
Completed NCT02773849 - ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Phase 3
Recruiting NCT03379909 - Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer Phase 2
Completed NCT00782587 - Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer Phase 1
Recruiting NCT05084586 - Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation N/A
Recruiting NCT03121768 - A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) N/A
Completed NCT03091764 - Evaluation of a Patient-Reported Symptom Index for NMIBC
Completed NCT01939756 - Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms Phase 1/Phase 2
Completed NCT00595088 - Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer Phase 2
Completed NCT02007005 - Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT01149174 - Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer Phase 3
Completed NCT00322699 - Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer Phase 1/Phase 2
Completed NCT00191711 - Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk. Phase 2
Completed NCT00192049 - A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer Phase 2
Recruiting NCT04752722 - LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve Phase 1/Phase 2
Recruiting NCT02106572 - Therapeutic Instillation of Mistletoe Phase 3
Completed NCT00734994 - Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer Phase 0