Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Section NCT
Category Urogenital tumors
Subcategory Urothelial carcinoma of the urinary bladder (incl. renal pelvis, ureter)
Trial Type Neoadjuvant Therapy
Description for experts The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is todetermine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinicalefficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activityat the RP2D. Part 4 (RP2D expansion) will assess the overall complete response (CR) inparticipants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; meansthe cancer cells are only in the bladder's inner lining).
Description for laymen The study is for patients with localized urothelial carcinoma of the bladder. A pretzel with erdafitinib (TAR-210) is to be inserted into the bladder in order to obtain this.
JSON Data { "short_title": "Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer", "data_mode": "900", "data_mode_number": "000002472", "official_title": "Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer", "accrual_state": "planned", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "not_applicable", "ctgov_number": "NCT05316155", "eudract_number": "2021-004144-22", "general_contact_email": "UroStudienKoordination@ukdd.de", "general_contact_phone": "+49 351-4582157", "hauptpruefer_dd_name": "Prof. Dr. med. Christian Thomas", "description_laie_de": "Die Studie ist f\u00fcr Patienten mit lokalem Urothelkarzinom der Harnblase. Um diese zu erhalten, soll eine Brezel mit Erdafitinib (TAR-210) in die Blase eingesetzt werden.", "description_laie_en": "The study is for patients with localized urothelial carcinoma of the bladder. A pretzel with erdafitinib (TAR-210) is to be inserted into the bladder in order to obtain this.", "description_expert_de": "Zweck der Studie in Teil 1 (Dosiseskalation) und in Teil 2 (Dosisausweitung) ist es, die empfohlene(n) Dosis(en) der Phase 2 (RP2D[s]) zu bestimmen und die vorl\u00e4ufige klinische Wirksamkeit zu bewerten. In Teil 3 (Dosisausweitung) werden die Sicherheit und die vorl\u00e4ufige klinische Aktivit\u00e4t bei der RP2D best\u00e4tigt. In Teil 4 (RP2D-Erweiterung) wird das vollst\u00e4ndige Ansprechen (CR) bei Teilnehmern mit nicht-muskelinvasivem Blasenkrebs mit mittlerem Risiko (IR-NMIBC; d. h. die Krebszellen befinden sich nur in der Blasenschleimhaut) bewertet.\r\n\r\n\u00dcbersetzt mit DeepL.com (kostenlose Version)", "description_expert_en": "The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is todetermine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinicalefficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activityat the RP2D. Part 4 (RP2D expansion) will assess the overall complete response (CR) inparticipants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; meansthe cancer cells are only in the bladder's inner lining).", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I_II", "main_cat_id": 11, "sub_cat_id": 52 }
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Short name 900-000002472