Afficher de nouveau l’introduction
NCT02640534 | SNCTP000001345

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

Base de données : BASEC (Importation du 16.08.2019), WHO (Importation du 04.08.2019)
Modifié: 17.05.2019
Catégorie de maladie: Prostatakrebs

Brève description de l’étude (Source de données: 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.

Maladies étudiées (Source de données: BASEC)

Metastasierter Prostatakrebs

Health conditions (Source de données: WHO)

Cancer of the Prostate

Maladie rare (Source de données: BASEC)


Intervention étudiée (p. ex., médicament, thérapie, campagne) (Source de données: BASEC)

Sie werden nach einem Zufallsprinzip einer Behandlung (Arm A: Metformin + Enzalutamid

Interventions (Source de données: WHO)

Drug: Enzalutamide

Critères de participation à l’étude (Source de données: BASEC)

- Prostatakrebs mit Metastasen
- Kein Ansprechen mehr auf alleinige Standardhormontherapie

Critères d’exclusion (Source de données: 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 (Source de données: WHO)

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

- 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

- 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, ODM201, ARN509),

- 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 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

- 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

- 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.

Plus de données sur l’étude tirée du registre primaire de l’OMS

Plus de données sur l’étude tirée de la base de données de l’OMS (ICTRP)

Plus d’informations sur l’étude

Date d’enregistrement de l’étude


Intégration du premier participant


Statut de recrutement


Titre scientifique (Source de données: 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

Type d’étude (Source de données: WHO)


Conception de l’étude (Source de données: WHO)

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

Phase (Source de données: WHO)

Phase 2

Points finaux primaires (Source de données: WHO)

Disease control (DC)

Points finaux secondaires (Source de données: WHO)

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

Contact pour informations (Source de données: WHO)

Please refer to primary and secondary sponsors

Lieux de réalisation des études

Lieux de réalisation des études en Suisse (Source de données: BASEC)

Aarau, Baden, Basel, Bellinzona, Chur, Frauenfeld/Münsterlingen, Freiburg, Genf, Lausanne, Luzern, Olten, Sion, Sion mit Subzentrum Martigny, Solothurn, St Gallen, Winterthur, Zürich

Pays où sont réalisées les études (Source de données: WHO)


Contact pour plus d’informations sur l’étude

Données sur la personne de contact en Suisse (Source de données: BASEC)

Eloïse Kremer
+41 31 389 91 91

Contact pour des informations générales (Source de données: WHO)

Christian Rothermundt, MD
Cantonal Hospital of St. Gallen

Contact pour des informations scientifiques (Source de données: WHO)

Christian Rothermundt, MD
Cantonal Hospital of St. Gallen

Responsables de l’étude

Promoteur principal (Source de données: WHO)

Swiss Group for Clinical Cancer Research

Plus de numéros d’identification d’étude

BASEC ID (Source de données: BASEC)


Secondary ID (Source de données: WHO)