Orion-BC
Research type
Research Study
Full 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
IRAS ID
1010704
Contact name
Nicola Giordan
Contact email
Sponsor organisation
Fidia Farmaceutici S.p.A.
Clinicaltrials.gov Identifier
Research summary
Bladder cancer is a heterogenous disease. Standard treatment involves immunotherapy drug Bacillus Calmette Guerin (BCG) which helps the immune system fight off the cancer. However, there is a likelihood of reoccurrence.
The purpose of this study is to understand if the investigational drug, ONCOFID-P-B, is effective and safe in treating patients with carcinoma in situ of the bladder (bladder cancer) who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy (removing the bladder).
The study drug, ONCOFID-P-B, is a new anticancer drug made of two components: paclitaxel and hyaluronic acid. It will be administered directly into the bladder. ONCOFID-P-B has shown activity towards bladder tumours in laboratory conditions and in previous research studies when administered to patients suffering from bladder cancer.
Up to 149 participants at approximately 45 study sites across the world will take part in this study. All participants in this study will receive the same dose of the study drug, 600 mg.
Participant duration in this study will be a maximum of 53 months (approximately 4 and a half years) consisting of a screening period of up to 4 weeks (1 month) followed by up to 46 study visits to the study site during a treatment period of up to 18 months, and a follow-up period of up to 32 months.
Based on previous studies with ONCOFID-P-B, side effects are expected to be limited to local discomfort, but participants may also experience nausea, blood in urine, excess protein in urine, hives, urinary tract infection, bladder discomfort, difficult/painful urination, sudden urge to urinate, reduced bladder capacity, diarrhoea, and/or abnormal sensation in the mouth.
Participants may or may not benefit as a result of their participation in this study. However, results from this study may benefit others in the future, as the information collected may help patients with the same disease get better care in future years.REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0056
Date of REC Opinion
11 Mar 2025
REC opinion
Further Information Favourable Opinion