NCT04661826

ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.

ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.

Detailed description

This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder. Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.

Conditions

• Non-Invasive Papillary Carcinoma of Bladder

Interventions

Type	Name	Description
DRUG	Oncofid-P-B	Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.

Timeline

• Start date: 2010-05-17
• Primary completion: 2015-07-29
• Completion: 2016-10-04
• First posted: 2020-12-10
• Last updated: 2020-12-10

Locations

14 sites across 3 countries: Germany, Italy, Spain