StudyFinder
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
Status: Recruiting
The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:
• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Interventions:
Drug: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Bladder Cancer in Situ (CIS), Bladder CIS
Study Contact: Danniella Balangoy - balan017@umn.edu
Principal Investigator: Hamed Ahmadi
Phase: PHASE3
IRB Number: STUDY00019273
See this study on ClinicalTrials.gov