NCT01878188

Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

Phase I Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Anchiano Therapeutics Israel Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* Safety and tolerability of three regimens of intravesically administered BC-819/PEI and BCG (number of participants with AEs, discontinuations due to AEs) * Recurrence after treatment with BC-819/PEI and BCG * Approximately 38 patients with superficial transitional cell carcinoma TCC) of the bladder * After initial evaluation and qualification, patients will be randomized to one of three treatment groups, either alternating, sequential or twice weekly

Conditions

• Transitional Cell Carcinoma of Bladder

Interventions

Type	Name	Description
DRUG	BC-819/PEI	Intravesical instillation
DRUG	BCG Vaccine	intravesical instillations

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-10-01
• Completion: 2017-10-01
• First posted: 2013-06-14
• Last updated: 2019-03-11

Locations

7 sites across 1 country: Israel