E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bladder Cancer Stage 1 without Cancer in Situ
Patients will have transitional-cell carcinoma of the bladder, clinical TNM stage Ta or T1 and histologic grade G1 or G2 before transurethral resection. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005009 |
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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 |
To investigate the safety of a single immediate post-TUR intravesical instillation of 4 mg/40 ml EOquin |
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E.2.2 | Secondary objectives of the trial |
To evaluate the pharmacokinetics of EOquin™ following immediate post-TUR intravesical instillation. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
All of the following inclusion criteria must be met in order for the patient to be eligible for the study: 1. Transitional-cell carcinoma of the bladder, clinical TNM stage Ta or T1 and histologic grade G1 or G2 before transurethral resection. 2. Absolute neutrophil count ≥1.5 x109/L, platelets ≥ 100 x109/L, serum creatinine and bilirubin ≤ 1.5 x upper limit of local norm (ULN), serum GOP and GPT ≤ 3 xULN 3. Women of child-bearing age must have a negative pregnancy test. 4. All patients must agree to use an effective method of contraception 5. ECOG performance status of 0-2 6. Age ≥18 7. Patient fully informed of the investigational nature of the study; signed written informed consent
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E.4 | Principal exclusion criteria |
1. Likelihood of muscle-invasive (T2) or higher stage disease, or carcinoma in situ. 2. Recurrence within 3 months from the last previous manifestation of SBC 3. More than 5 lesions or largest diameter ≥ 4 cm 4. Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months 5. Previous treatment with EOquin™ by intravesical or intravenous administration 6. Patients with other malignancies except resected basal cell cancer/squamous carcinoma of the skin 7. Patients with any significant GU disease 8. Patients with prior intravesical BCG therapy 9. Patients with bladder perforation, suspected bladder perforation, or deep resection exposing perivesical fat. 10. Active urinary tract infection or recurrent severe bacterial cystitis 11. Urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra 12. Patients who, in the opinion of the investigator, cannot tolerate general anesthesia, intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders) 13. Pregnancy or lactation. Any immune deficiency condition or known HIV infection 14. Patient unlikely to comply with the provisions of the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is to be determined by 2 main assessments: 1. Presence, severity and frequency of adverse events / toxicities in the 2 weeks following the instillation 2. For the first 10 patients with low-risk histology, cystoscopic evaluation of bladder epithelium approximately 3 months (10-13 weeks) after immediate post-TUR instillation Patients will be initially enrolled in the study based on the Investigator's judgment of the probable stage and grade of the tumor. Clinical assessment of the probable tumor stage and grade and adequacy of the resection will be confirmed only later by histopathologic examination of the resection specimen. As a result, all patients enrolled in the study will have received an immediate post-TUR instillation of EOquin™. A first instillation of a cytotoxic agent within few hours from TUR is a generally recommended initial treatment for patients presenting with superficial bladder cancer of all histologic grades at stages Ta and T1, even if further instillation treatment with BCG or cytostatics is indicated because of other prognostic characteristics. The need for those patients to receive further instillation therapy, which is generally given approximately 2 weeks after TUR, will preclude them from being evaluable at the cystoscopy approximately 3 months after TUR. These higher risk patients will receive further instillation therapy after their evaluation on day 15 of this study.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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20 evaluable patients who have completed the 3 months cystoscopy evaluation. |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |