E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The medical condition under investigation is noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005005 |
E.1.2 | Term | Bladder cancer recurrent |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005007 |
E.1.2 | Term | Bladder cancer stage 0, without cancer in situ |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10005003 |
E.1.2 | Term | Bladder cancer |
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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 evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive transurethral recection of bladder tumor (TUR-BT) plus EOquin® versus those who receive TUR-BT plus placebo. |
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E.2.2 | Secondary objectives of the trial |
1) To evaluate time to first recurrence in patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo. 2) To evaluate progression to higher stage or grade, number of recurrences per patient, disease free interval, disease free survival and overall survival. 3) To assess the safety of EOquin® instilled into the bladder in the early postoperative period. 4)To assess functional bladder capacity in a 150 subject subset of randomized patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patient provides written informed consent. 2. Patient at least 18 years old. 3. Patient has transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2. 4. If the patient is a female of childbearing potential, is using an acceptable/effective method of contraception. 5. If the patient is a female of childbearing potential, she has had a negative serum pregnancy test within the past 14 days. 6. Patient willing and able to abide by the protocol. |
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E.4 | Principal exclusion criteria |
1. Patient may not have more than 4 bladder tumors. 2. Any single bladder tumor may not exceed 3.5 cm in diameter. 3. Patient must not have a single, primary bladder tumor <0.5 cm and have no previous diagnosis of bladder cancer. 4. Patient cannot have ever received EOquin®. 5. Patient cannot have, or ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade [WHO/ISUP classification]). 6. Patient cannot have, or ever had any bladder tumor with histology other than transitional cell carcinoma. 7. Patient cannot have, or ever had, CIS. 8. Patient cannot have an active urinary tract infection. 9. Patient cannot have a bleeding disorder or a screening platelet count < 100 x 10 9/L. 10. Patient cannot have any unstable medical condition that would make it unsafe for him/her to undergo TUR-BT under general or spinal anesthesia. 11. Patient cannot have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L or a screening creatinine > 2 mg/dL. 12. Patient cannot have a known immunodeficiency disorder. 13. Patient cannot have received any investigational treatment within the past 30 days. 14. Patient cannot be breast feeding. 15. Patient cannot have a history of interstitial cystitis. 16. Patient cannot have a history of allergy to red color food dye. 17. Patient cannot have had transitional cell carcinoma of the bladder within the past 4 months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy assessment will be the recurrence rate at 2 years in patients with Ta, G1-G2 histology receiving one immediate instillation of EOquin® or placebo following TUR-BT. These patients will be assessed cystoscopically at 3-month intervals calculated from the time of randomization day. For patients with higher grade and stage tumors, for tumors other than stage Ta, and grade G1-G2 recurrence will be assessed cystoscopically at 3-month intervals calculated from the time of start of their additional chemo- or immunotherapy. The date of the biopsy procedure at which the bladder tumor was confirmed histologically will be used as the date of recurrence. Tumor stage and grade will be assessed by a blinded central laboratory that specializes in urologic pathology. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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 | 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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Provided in the Protocol. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |