Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Ziel dieser multizentrischen Studie ist die Beurteilung der Sicherheit von Atezolizumab als Zweitlinientherapie für Patienten mit lokal fortgeschrittenem oder metastasiertem Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege. Ausserdem sollen die Wirksamkeit von Atezolizumab sowie potenzielle Tumor-Biomarker im Zusammenhang mit Atezolizumab untersucht werden.
Malattie studiate(Fonte di dati: BASEC)
Ein Urothelkarzinom ist eine Krebsart, die in den Harnwegen auftritt. Dazu gehören Blasenkrebs, Harnleiterkrebs und Nierenbeckenkrebs.
Health conditions
(Fonte di dati: WHO)
Urinary Tract Cancer
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Atezolizumab wird einmal alle drei Wochen als intravenöse Infusion verabreicht (es wird eine kleine Nadel in eine Vene gelegt). Jede Infusion enthält 1200 mg des therapeutischen Antikörpers.
Die Teilnehmer müssen für die Verabreichung der Atezolizumab-Infusionen alle 3 Wochen ins Studienzentrum kommen, sodass das Studienpersonal die Verabreichung überwachen und bei medizinischen Notfällen reagieren kann.
Die Teilnehmer werden gebeten, 30 Tage nach ihrer letzten Atezolizumab-Infusion zu einem weiteren Termin ins Studienzentrum zu kommen. Die Teilnehmer werden über einen Zeitraum von 4 Jahren nach ihrer letzten Atezolizumab-Infusion auch alle 3 Monate angerufen.
Interventions
(Fonte di dati: WHO)
Drug: Atezolizumab
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
• Teilnehmer mit histologisch dokumentiertem lokal fortgeschrittenem oder metastasiertem Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege
• Teilnehmer mit messbarem und nicht messbarem Tumorbefall gemäss RECIST-Kriterien Version 1.1
• Die Patienten müssen eine vorherige Kombinationschemotherapie gegen das inoperable, lokal fortgeschrittene oder metastasierte Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege erhalten haben
• Repräsentative formalinfixierte und in Paraffin eingebettete Tumorprobe
• ECOG-Leistungsstatus (Eastern Cooperative Oncology Group) 0, 1 oder 2
Criteri di esclusione
(Fonte di dati: BASEC)
• Behandlung mit mehr als einer vorherigen systemischen Therapielinie bei inoperablem, lokal fortgeschrittenem oder metastasiertem Urothelkarzinom oder Nicht-Urothelkarzinom der Harnwege
• Behandlung mit anderen Prüfpräparaten oder Teilnahme an einer anderen therapeutischen klinischen Studie innerhalb von 4 Wochen vor Beginn der Studienbehandlung
• Anzeichen einer signifikanten unkontrollierten Begleiterkrankung, die die Einhaltung des Protokolls beeinträchtigen könnte
• Signifikante Nierenerkrankung, die eine Dialysebehandlung notwendig macht, oder Indikation für eine Nierentransplantation
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Inclusion Criteria:
- Participants with histologically documented locally advanced (tumor [T] 4b, any node
[N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial
carcinoma of the urinary tract
- Participants with measurable and/or non-measurable disease according to RECIST v1.1
- Participants must have progressed during or following treatment with at least one
prior (and not more than 3) treatments for inoperable, locally advanced or metastatic
urothelial or non-urothelial carcinoma of the urinary tract
- If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen
block should be submitted
- Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
Exclusion Criteria:
- Treatment with more than three prior lines of systemic therapy for inoperable, locally
advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- Treatment with any other investigational agent or participation in another clinical
trial with therapeutic intent within 4 weeks prior to study treatment initiation
1. Participants who were in another clinical trial with therapeutic intent within 4
weeks of study treatment initiation but were not on active drug in that prior
trial are eligible
2. Participants who were in another clinical trial with therapeutic intent within 4
weeks of study treatment initiation but were in the follow-up phase of that prior
trial and had stopped receiving active drug 4 or more weeks before study
treatment initiation are eligible
- Malignancies other than the one studied in this protocol within 5 years prior to Cycle
1, Day 1
- Evidence of significant uncontrolled concomitant disease that could affect compliance
with the protocol
- Significant renal disorder indicating a need for renal transplant
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
7 ott 2016
Inserimento del primo partecipante
30 nov 2016
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
An Open Label, Single Arm, Multicenter, Safety Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
Percentage of Participants With Adverse Events
Punti finali secondari
(Fonte di dati: WHO)
Overall Survival (OS);Progression Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1);PFS as per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST);Percentage of Participants With Best Overall Response as Assessed by RECIST v1.1;Percentage of Participants With Best Overall Response as Assessed by Modified RECIST;Percentage of Participants With Disease Control as Assessed by RECIST v1.1;Percentage of Participants With Disease Control as Assessed by Modified RECIST;Duration of Response as Assessed by RECIST v1.1;Duration of Response as Assessed by Modified RECIST;Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score;Change from Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Basilea, Berna, Chur, Ginevra, Lugano, Winterthur
Paesi di esecuzione
(Fonte di dati: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Czechia, Denmark, Egypt, Estonia, Germany, Greece, Hungary, India, Ireland, Italy, Lebanon, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Swaziland, Switzerland, Taiwan, Turkey, United Kingdom
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Clinical Trials
+41 61 715 43 91
switzerland.clinical-research@roche.com
Contatto per informazioni generali
(Fonte di dati: WHO)
Clinical Trials
Hoffmann-La Roche
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Clinical Trials
Hoffmann-La Roche
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Bern
Data di autorizzazione da parte della commissione d’etica
01.02.2017
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2016-01933
Secondary ID (Fonte di dati: WHO)
2016-002625-11
MO29983
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