E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male and females patients affected by multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder will be inlcuded in the study. |
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E.1.1.1 | Medical condition in easily understood language |
Superficial bladder cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate time to relapse after Oncofid-P-B instillation during the maintenance phase.
- To determine number and percentage of patients with relapse within V22.
- To evaluate the safety profile of Oncofid-P-B given by intravesical instillation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 primary or recurrent Ta G1-G2 papillary cancer;
- ECOG Performance Status 0 to 1 ;
- Adequate bone marrow function: neutrophils ≥1.5 103/mL; platelet count ≥100 103/ mm3; Hb ≥ 10 g/dL;
- Written informed consent;
- Willing and able to comply with the protocol for the duration of the study |
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E.4 | Principal exclusion criteria |
- Hypersensitivity to Paclitaxel or one of its constituents;
- T1 papillary cancer or muscle-invasive disease (T2-T4) ;
- Previous or concomitant cancer of the upper urinary tract, of the prosthatic urethra, carcinoma in situ (CIS);
- Any other malignancy diagnosed within 3 years of study entry (except basal or sqamous cell skin cancers or non-invasive cancer of the cervix);
- Presence of significant urologic disease interfering with intravesical therapy;
- Participation in another clinical trial with any investigational drugs within 30 days prior to study screening or concurrent treatment with other experimental drugs;
- Other chemotherapy or radiotherapy within four weeks of study entry;
- Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry;
- Bladder capacity less than 300 mL;
- Renal and hepatic function values exceeding 2 times the upper normal value;
- Severe cardiovascular diseases considered a contraindication to intravesical treatment;
- Pregnant, lactating or childbearing potential aged women. |
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E.5 End points |
E.5.1 | 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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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Estimated at V8, after 6 weeks of weekly study drug administration. |
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E.5.2 | Secondary end point(s) |
To evaluate time to relapse after Oncofid-P-B instillation during the maintenance phase
To determine number and percentage of patients with relapse within V22.
To evaluate the safety profile of Oncofid-P-B given by intravesical instillation. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Visit Last Patient (LVLS) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |