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

Sponsor:

Fidia Farmaceutici

Sponsor Study ID:

R39_21_01

CTO #:

103819

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).

eConsent:

Not available

Study Documents:

Open Study Documents
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