NCT01731652

Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Telormedix SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.

Detailed description

This study is an open label, pilot study of TMX-101 in the treatment of carcinoma in situ. TMX-101 is a new formulation of Imiquimod optimized for intravesical delivery. Imiquimod possesses immune-stimulatory properties. TMX-101 is being developed as a potential treatment for patients with non-invasive bladder cancer, including patients with CIS bladder cancer. Following confirmation of CIS by histology, patients will receive weekly instillations of TMX-101 for 6 weeks. Five to seven weeks after the last instillation, biopsies and cytology will be performed. Response to treatment will be determined based on cytology and tissue sample histology findings.

Conditions

• Carcinoma in Situ
• Non Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	TMX-101

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-10-01
• First posted: 2012-11-22
• Last updated: 2015-02-10

Locations

4 sites across 1 country: United States