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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

Data source: BASEC (Imported from 24.11.2020), WHO (Imported from 22.11.2020)
Changed: 27.09.2020
Disease category: Prostate Cancer, Breast Cancer

Brief description of trial (Data source: 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.

Health conditions investigated (Data source: BASEC)

(Knochenmetastasen) von Brust- respektive Prostatakrebs

Health conditions (Data source: WHO)

Metastatic Breast Cancer;Metastatic Prostate Cancer;Bone Metastases

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Xgeva® (Denosumab)

Interventions (Data source: WHO)

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

Criteria for participation in trial (Data source: 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.

Exclusion criteria (Data source: 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 (Data source: 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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02051218

Further information on the trial from WHO database (ICTRP)

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

Further information on trial

Date trial registered

29.01.2014

Incorporation of the first participant

16.07.2014

Recruitment status

Recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: 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).

Secundary end point (Data source: 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)

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Baden, Basel, Bellinzona, Bern, Biel, Brig, Chur, Frauenfeld, Freiburg, Geneva, Lausanne, Liestal, Locarno, Lugano, Luzern, Münsterlingen, Olten, Schlieren, Sion, Solothurn, St. Gallen, Thun, Winterthur, Zurich

Countries (Data source: WHO)

Austria, Germany, Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

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

Contact for general information (Data source: 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

Contact for scientific information (Data source: 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

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Swiss Group for Clinical Cancer Research

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Further trial identification numbers

Secondary ID (Data source: WHO)

000000685
2014-001189-87
SAKK 96/12