Carcinoma in Situ Clinical Trial
Official title:
Phase II Pilot Study With TMX 101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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