Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A Phase III, Single Arm Study to Evaluate the Efficacy and Safety of ONCOFID P B (paclitaxel hyaluronic acid conjugate) Administered Intravesically to Patients with BCG unresponsive Carcinoma in Situ of the Bladder with or without Ta T1 Papillary Disease
NCT Number:
NCT05024773
Phase:
III
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Bladder
Study Objectives:
To evaluate the antitumor activity of ONCOFID-P-B using centrally assessed complete response rate (CRR) following 12 weekly intravesical instillations (induction phase). To further evaluate the antitumor activity of ONCOFID-P-B using centrally assessed CRR at 6, 9, 18 and 24 months after treatment start. To evaluate the duration of response (DoR). To evaluate the DoR rates at 6, 9, 12, 15, 18, 21 and 24 months after treatment start. To evaluate progression rates at 3, 15 and 24 months after treatment
start. To evaluate time to progression. To evaluate the rate of patients undergoing cystectomy at 3, 15 and
24 months after treatment start. To evaluate event-free survival (EFS). To evaluate overall survival (OS).
Study Documents
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