E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 assess efficacy of intravesical gemcitabine in patients with bladder cancer |
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E.2.2 | Secondary objectives of the trial |
To assess safety and tolerability of intravesical gemcitabine in patients with bladder cancer |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening - On screening cystoscopy: Diameter of the largest lesion ≤15mm Number of lesions ≤5 Version 1.1; 04.12.2022 - Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation - Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk) - NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT) - Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening - No lymph node metastasis or distant metastasis |
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E.4 | Principal exclusion criteria |
- Tumors that clinicians suspect to be HG - Positive HG cytology according to Paris criteria - Diameter of tumor >15 mm - Number of lesions >5 - Any previous intravesical therapy within 1 year - Previous HG NMIBC - Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC - History of upper tract urothelial carcinoma (UTUC) - Clinically significant urethral stricture that would preclude passage of a urethral catheter - History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding - Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment - Patient refused to participate |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Pathological complete response (pCR) Overall response (cCR + pCR) Safety (AEs and TRAEs) Rate of treatment discontinuation (at least 5 from 6 instillations within 8 weeks) Clinical response of photo review by external independent blinded committee Health-related quality of life (EORTC QLQ-NMIBC24 and EORTC QLQ-C30) |
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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 | 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) | 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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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The end of the trial is defined as the date of the last visit of the last patient undergoing the trial |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |