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SNCTP000000685 | NCT02051218

SAKK 96/12 - Verhinderung von symptomatischen Komplikationen am Skelett mit Denosumab verabreicht alle 4 Wochen gegenüber alle 12 Wochen

Base di dati: BASEC (Importata da 24.11.2020), WHO (Importata da 22.11.2020)
Cambiato: 27.09.2020
Categoria di malattie: Cancro della prostata, Cancro del seno

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Der Wirkstoff im Medikament Xgeva® (Denosumab) ist ein sogenannter Antikörper. Es handelt sich dabei um ein Eiweiss von ähnlicher Struktur, wie es auch von unserem eigenen Immunsystem bei Infektionen produziert wird. Dieses Eiweiss hemmt gezielt die knochenabbauenden Zellen (Osteoklasten) in ihrer Reifung als auch deren Aktivität und schützt so den Knochen vor der Zerstörung durch den Tumor. Dieses Eiweiss wird im Körper wieder verdaut und belastet weder die Nieren noch die Leber.
Resultate von mehreren klinischen Studien deuten darauf hin, dass die Verabreichung von Xgeva® alle 12 Wochen gleich wirksam ist wie die Verabreichung von Xgeva® alle 4 Wochen (Standardbehandlung). Deshalb möchten wir mit dieser Studie überprüfen, ob eine Injektion von Xgeva® alle 12 Wochen vergleichbar wirksam ist wie die Verabreichung alle 4 Wochen. Neben der Wirksamkeit werden auch die Nebenwirkungen genau beobachtet. Dabei möchten wir überprüfen, ob durch die reduzierte Verabreichung von Xgeva® Nebenwirkungen sogar weniger häufig auftreten.

Malattie studiate (Fonte di dati: BASEC)

(Knochenmetastasen) von Brust- respektive Prostatakrebs

Health conditions (Fonte di dati: WHO)

Metastatic Breast Cancer;Metastatic Prostate Cancer;Bone Metastases

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

Xgeva® (Denosumab)

Interventions (Fonte di dati: WHO)

Drug: Denosumab (reduced dosing);Drug: Denosumab (standard dosing)

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

- Der Patient/die Patientin hat die Teilnahme schriftlich zugestimmt.
- Für Brustkrebspatienten: Histologische bestätigen Diagnose vor Randomisation
- Für Prostatakrebspatienten: Histologische oder zytologische bestätigen Diagnose vor Randomisation
- Patienten mit Brustkrebs (Stadium IV, alle Subtypen, ausser klein zellig Brustkrebs) oder mit Prostatakrebs (Stadium IV, ausser klein
zellig Prostatakrebs) mit Knochenmetastasen welche eine antineoplastische Behandlungen bekommen sollen
- Patienten mit Prostatakrebs sollen einen Progression der Krankheit während der kontinuierlich Androgen Deprivation Therapie (CRPC)
gehabt haben
- Patienten sollen ≥ 3 Knochenmetastasen (Lytische oder Blastische oder gemischte). Die Läsionen sollen 12 Wochen vor Randomisation
dank radiologischen Evaluationen (d.h. X-ray, CT-scan, PET-CT, MRI oder Knochenszintigraphie) dokumentiert sein.
- WHO performance status 0-2
- Alter ≥ 18 Jahre.

Criteri di esclusione (Fonte di dati: BASEC)

- Kontraindikationen für Denosumab (z.B. Hypokalzämie)
- Anamnese oder Hinweis von Osteonekrose des Kiefers
- Kiefer oder Zahnkonditionen die eine orale Chirurgie benötigen oder chirurgische Eingriffe oder invasive zahnärztlichen Behandlungen
geplant sind

Inclusion/Exclusion Criteria (Fonte di dati: WHO)


Inclusion Criteria:

- Patient has given written informed consent.

- Histologically confirmed diagnosis of breast or prostate cancer before randomization.

- Patient has metastatic breast cancer (stage IV, all subtypes allowed) or prostate
cancer (stage IV) and bone metastases and is planned to receive or is receiving
antineoplastic treatment.

- Patients with prostate cancer must have evidence of disease progression on continuous
androgen deprivation therapy (CRPC).

- Patients must have = 3 bone metastases (lytic or blastic or mixed). The lesions must
be documented by radiological evaluation within 12 weeks before randomization (by
X-Ray, CT scan, PET-CT, MRI scan or bone scintigraphy).

- WHO performance status 0-2

- Age = 18 years.

- Corrected serum calcium = 2 mmol/l and = 3 mmol/l (medical treatments to obtain serum
calcium levels in the normal range are allowed, as far as no denosumab is used.
Maximally 1 dose of bisphosphonates in the case of hypercalcemia is allowed, if the
bisphosphonate was applied at least 3 weeks before the first dose of denosumab).

- Liver transaminases not more than 1.5 x ULN or not more than 3 x ULN with liver
metastases. Serum total bilirubin = 1.5 x ULN (= 2.0 x ULN in case of known Gilbert's
disease)

- Women are not breastfeeding. Women with child-bearing potential are using effective
contraception, are not pregnant and agree not to become pregnant during participation
in the trial and during the 12 months thereafter. A negative pregnancy test before
inclusion (within 7 days) into the trial is required for all women with child-bearing
potential.

- Men agree not to father a child during participation in the trial and during 12 months
thereafter.

Exclusion Criteria:

- Definite contraindication for denosumab (e.g. hypocalcaemia [Albumin-corrected serum
calcium < 2.0 mmol/l]).

- History or current evidence of osteonecrosis of the jaw.

- Non-healed mucosa in oral cavity (by surgery or as a side effect of any other
treatment).

- Jaw or dental conditions that require oral surgery or if surgery or invasive dental
procedures are planned.

- Prior use of denosumab for bone metastases (dose 120 mg every 4 weeks) or
bisphosphonates to treat bone metastases. Patients treated with denosumab or
bisphosphonates against osteopenia or osteoporosis are allowed to enter the trial if
the last dose was more than 28 days before randomization.

- Patients with known osteoporosis (T-score = -2.5) at study entry (since fractures from
osteoporosis are difficult to be discriminated from fractures through bone
metastases).

- Radiotherapy or surgery to the bone within the last two weeks before randomization or
planned within 6 weeks after randomization.

- Presence or history of CNS metastases or leptomeningeal disease. A MRI evaluation
within 12 weeks before randomization must be performed in case of suspicious symptoms.

- Psychiatric disorder precluding understanding of information on trial related topics,
giving informed consent, filling out QoL forms.

- Concurrent treatment in a clinical trial with SSE or SRE as primary endpoint.

- Known hypersensitivity to trial drug or hypersensitivity to any other component of the
trial drug (e.g. fructose).

- Any concomitant drugs contraindicated for use with the trial drugs according to the
approved product information.

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the trial protocol.

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT02051218

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02051218

Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

29.01.2014

Inserimento del primo partecipante

16.07.2014

Stato di reclutamento

Recruiting

Titolo scientifico (Fonte di dati: WHO)

Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks - A Non-Inferiority Phase III Trial

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).

Fase (Fonte di dati: WHO)

Phase 3

Punti finali primari (Fonte di dati: WHO)

Time to first on-trial symptomatic skeletal event (SSE; Clinically significant pathological fracture, radiation therapy to bone, surgery to bone or spinal cord compression).

Punti finali secondari (Fonte di dati: WHO)

Overall Survival (OS);Bone turnover markers;Health economic analysis;Skeletal morbidity rate (SMR);Skeletal morbidity period rate (SMPR);Quality of Life measured by FACT-G and FACT-BP;Time to first and subsequent on-trial SSE;Toxicity (focus on hypocalcaemia and osteonecrosis of the jaw)

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)

Aarau, Baden, Basilea, Bellinzona, Berna, Biel, Brig, Chur, Frauenfeld, Friburgo, Ginevra, Liestal, Locarno, Losanna, Lugano, Luzern, Münsterlingen, Olten, San Gallo, Schlieren, Sion, Solothurn, Thun, Winterthur, Zurigo

Paesi di esecuzione (Fonte di dati: WHO)

Austria, Germany, Switzerland

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

Fuhrer Andrea
+41 31 508 41 51
trials@sakk.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Roger von Moos, PD MD;Arnoud Templeton, MD;Silke Gillessen, Prof;Andreas Müller, MD;Corinne Schär, PhD
Kantonsspital Graubünden;Cantonal Hospital of St. Gallen;Kantonsspital Winterthur KSW
+41 31 389 91 91
trials@sakk.ch

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Roger von Moos, PD MD;Arnoud Templeton, MD;Silke Gillessen, Prof;Andreas Müller, MD;Corinne Schär, PhD
Kantonsspital Graubünden;Cantonal Hospital of St. Gallen;Kantonsspital Winterthur KSW
+41 31 389 91 91
trials@sakk.ch

Responsabile della sperimentazione

Sponsor principale (Fonte di dati: WHO)

Swiss Group for Clinical Cancer Research

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 Zürich

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

000000685
2014-001189-87
SAKK 96/12