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SNCTP000001345 | NCT02640534 | BASEC2016-00127

Untersuchung von Metformin bei Patienten mit kastrationsresistentem Prostatakarzinom in Kombination mit Enzalutamide vs. Enzalutamide alleine

Base di dati: BASEC (Importata da 28.03.2024), WHO (Importata da 20.03.2024)
Cambiato: 6 feb 2024, 11:13
Categoria di malattie: Cancro della prostata

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Der Zweck dieser Studie ist es, herauszufinden, ob die Kombination von Metformin, einem bekannten Blutzucker senkenden Medikament, mit Enzalutamid (Xtandi®) im Vergleich zu Enzalutamid alleine eine bessere Wirkung gegen metastasierten Prostatakrebs zeigt. Zudem soll die Sicherheit der Kombination erforscht werden.

Malattie studiate(Fonte di dati: BASEC)

Metastasierter Prostatakrebs

Health conditions (Fonte di dati: WHO)

Cancer of the Prostate;Prostate Cancer

Malattia rara (Fonte di dati: BASEC)

No

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

Sie werden nach einem Zufallsprinzip einer Behandlung (Arm A: Metformin + Enzalutamid; Arm B: Enzalutamid allein) zugeteilt. Wenn Sie mit Enzalutamid alleine behandelt werden erhalten Sie dieselbe Therapie wie sie der Standardbehandlung entspricht.

Interventions (Fonte di dati: WHO)

Drug: Enzalutamide;Drug: Metformin

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

- Prostatakrebs mit Metastasen
- Kein Ansprechen mehr auf alleinige Standardhormontherapie

Criteri di esclusione (Fonte di dati: BASEC)

- Patienten die weiterhin nicht mit Standardhormontherapie behandelt werden möchten,
- Patienten welche Erkrankungsherde im zentralen Nervensystem ausweisen,
- Patienten die grössere Operationen oder die welche eine Therapie zur Blutverdünnung mit Warfarin und Rivaroxaban benötigen

Inclusion/Exclusion Criteria (Fonte di dati: WHO)

Gender: Male
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Written informed consent according to ICH/GCP regulations before registration and
prior to any trial-related investigations

- Histologically or cytological confirmed adenocarcinoma of the prostate without small
cell carcinoma or small cell components

- Asymptomatic or minimally symptomatic patients in relation to disease

- Metastatic adenocarcinoma of the prostate documented by imaging (CT/MRI and/or bone
scan)

- Ongoing androgen deprivation therapy with Gonadotropin-releasing hormone GnRH
analogues or bilateral orchiectomy (i.e. surgical or medical castration)

- Total testosterone levels = 1.7 nmol/L (corresponding to = 50 ng/dL)

- Tumor progression at the time of registration, defined as per protocol.

- Completed baseline QoL and pain questionnaires

- Male patients = 18 years

- WHO performance status 0-2

- Adequate hematologic values: hemoglobin = 90 g/L, neutrophils = 1.0 x 109/L, platelets
= 75 x 109/L

- Adequate hepatic function: ALT and AST = 2.5 x ULN, bilirubin = 1.5 x ULN (exception
if Gilbert's syndrome = 2.5 x ULN)

- Adequate renal function: calculated creatinine clearance = 50 mL/min, according to the
formula of Cockcroft-Gault

- Patient is able to swallow the trial drugs and comply with trial requirements

- Patient agrees not to father a child during participation in the trial and during 3
months thereafter

- Patient agrees to participate to the mandatory translational research part of the
trial with exception of Pyruvate dehydrogenase sub-study.

Exclusion Criteria:

- Known or suspected Central nervous system CNS metastases or active leptomeningeal
disease

- Previous malignancy within 2 years prior to registration, with the exception of
localized non-melanoma skin cancer and Ta and Tis bladder cancer

- Prior treatment for prostate cancer with

- novel endocrine agents (including abiraterone acetate, enzalutamide, TAK-700,
TAK-683, TAK-448, VT464, darolutamide, apalutamide),

- radioisotopes,

- TKI and other small molecules,

- immunotherapy,

- chemotherapy (with the exception of docetaxel chemotherapy in hormone sensitive
prostate cancer)

- Treatment with experimental drugs or treatment within a clinical trial within 30 days
prior to registration (except the clinical trial SAKK 96/12, PEACE-4 and/or the
biobank project SAKK 63/12)

- Clinically significant cardiovascular disease including:

- Myocardial infarction within 6 months prior to registration,

- Uncontrolled angina within 3 months prior to registration,

- Congestive heart failure NYHA class III or IV,

- QTc interval > 480 ms,

- History of clinically significant ventricular arrhythmias (e.g. ventricular
tachycardia, ventricular fibrillation, torsades de pointes),

- History of Mobitz II second or third degree heart block without a permanent
pacemaker in place,

- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg OR
diastolic blood pressure > 105 mmHg

- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
investigator, would make the patient inappropriate for enrollment (e.g. uncontrolled
or acute severe infection, advanced chronic obstructive pulmonary disease, heart
failure)

- Known history of HIV, hepatitis B, hepatitis C

- Major surgery within 4 weeks prior to registration

- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer
disease within 3 months prior to registration)

- Treatment with metformin within the last 6 months prior to registration

- Patients on pharmacotherapy for diabetes mellitus

- History of diabetic ketoacidosis, diabetic coma and pre-coma

- Known history of seizures or any conditions that may predispose to seizure. History of
loss of consciousness or transient ischemic attack within 12 months prior to
registration

- Concurrent anticoagulation with rivaroxaban or warfarin

- Known hypersensitivity to the IMPs or hypersensitivity to any of their components

- Any concomitant drugs contraindicated for use with the IMPs according to the
Swissmedic approved product information

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

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT02640534

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

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02640534
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

22 dic 2015

Stato di reclutamento

Terminated

Titolo scientifico (Fonte di dati: WHO)

Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone (IMPROVE TRIAL): A Randomized, Open Label, Phase II Trial

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

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

Fase (Fonte di dati: WHO)

Phase 2

Punti finali primari (Fonte di dati: WHO)

Disease control (DC)

Punti finali secondari (Fonte di dati: WHO)

Overall response (OR);Event-free survival (EFS);Adverse events (AEs);Overall survival (OS)

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, Chur, Frauenfeld/Münsterlingen, Friburgo, Ginevra, Losanna, Luzern, Olten, San Gallo, Sion, Sion mit Subzentrum Martigny, Solothurn, Winterthur, Zurigo

Paesi di esecuzione (Fonte di dati: WHO)

Switzerland

Contatto per maggiori informazioni sulla sperimentazione

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

SAKK, Corinne Schär, PhD
+41 31 389 91 91
trials@sakk.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Christian Rothermundt, MD
Cantonal Hospital of St. Gallen

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Christian Rothermundt, MD
Cantonal Hospital of St. Gallen

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)

Ethikkommission Ostschweiz (EKOS)

Data di autorizzazione da parte della commissione d’etica

06.04.2016

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2016-00127

Secondary ID (Fonte di dati: WHO)

SAKK 08/14 - IMPROVE
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