Study of ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)
Status:
Completed
Trial end date:
2020-11-18
Target enrollment:
Participant gender:
Summary
Phase I exploratory, open-label, single arm, multicenter study to assess safety, tolerability
and antitumor activity of ONCOFID-P-B™ therapy in adult patients with histologically
confirmed diagnosis of bladder carcinoma in situ (CIS), who were unresponsive or intolerant
to Bacillus Calmette-Guérin (BCG)-therapy.
Patients are initially treated with 12 weekly intravesical instillations of ONCOFID-P-B™
(intensive treatment phase). Patients who achieve a complete response (CR) after the 12
weekly instillations entered the maintenance phase of the study, during which ONCOFID-P-B™ is
furtherly administered once a month for 12 months.