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TC-3 hydrogel · NMIBC TURBT HG

A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)

Ensayo de UroGen Pharma Ltd. en Non Muscle Invasive Bladder Cancer (del registro, en inglés).

Fase

Sin fase asignada

Estado

Retirado antes de empezar

Centros

1

Fin del objetivo primario

mar 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2013.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Change in the company clinical trials priority».

Qué mide

Ablative effect of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients (del registro, en inglés) (2 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic cystoscopy. The investigators believe that this study is of importance on several aspects: 1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode. 2. If proved effective, this mode of treatment might save the need for TURBT performance and serve as a new mode of tumor ablation. 3. Even if proved partially effective, this mode of treatment will diminish tumors size and/or number, thus enable a more limited TURBT procedure. 4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT. This might improve the patient's prognostic outcome. 5. If this experimental treatment will prove to have a better ablative effect in comparison to the standard of care known in the art, this could be translated to a better prophylactic effect of tumor recurrence. 6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence prevention will enable us to reduce adverse effects of higher drug dosage.

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Todos los de URGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01799499), actualizada en ago 2015.