ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012274-13-IT

Enrollment

Registered

2009-10-09

Start date

2009-09-17

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients affected by multiple recurrent Ta G1-G2 papillary cancer of the bladder. MedDRA version: 9.1 Level: LLT Classification code 10005003

Interventions

Product Name: ONCOFID-P-B Pharmaceutical Form: Bladder irrigation Current Sponsor code: ONCOFID-P20 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 750-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of both sexes, aged > 18 years, women in menopause (defined as surgically sterile or one year postmenopausal); Cytological or histological diagnosis of bladder cancer; Multiple recurrent Ta G1-G2 papillary cancer; ECOG Performance Status 0 to 1 ; Adequate bone marrow function: neutrophils = o sup. 1.500 mL; platelet count = o sup. 100.000 mm3; Hb = o sup. 10 g/dL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypersensitivity to Paclitaxel or one of its constituents; T1 and Muscle-invasive disease (T2-T4). Previous or concomitant cancer of the upper urinary tract, of the prosthatic urethra, carcinoma in situ (CIS); Any previous or concomitant malignancies other than superficial bladder cancer; Presence of significant urologic disease interfering with intravesical therapy; Other chemotherapy or radiotherapy within four weeks of study entry; Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 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;Secondary Objective: To evaluate time to relapse after Oncofid-P-B instillation during the maintenance phase; To determine number and percentage of patients with relapse within V 22. To evaluate the safety profile of Oncofid-P-B given by intravesical instillation.;Primary end point(s): To evaluate the rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. 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 sites and negative cytology.	—

Measure

Time frame

Main Objective: 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 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;Secondary Objective: To evaluate time to relapse after Oncofid-P-B instillation during the maintenance phase; To determine number and percentage of patients with relapse within V 22. To evaluate the safety profile of Oncofid-P-B given by intravesical instillation.;Primary end point(s): To evaluate the rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. 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 sites and negative cytology.

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Countries

Germany, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026