Subjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicty then subjects in the placebo arm.
ID
Bron
Verkorte titel
Aandoening
Breast cancer patients.
Ondersteuning
Ltd.Atago Green Hills MORI Tower 26F2-5-1, Atago
Minato-ku, Tokyo
105-6201 Japan
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Assessment of safety: <br>
this include evaluation of general safety (Blood pressure, heartrate, monitoring of the patient during infusion, laboratory tests, urinalysis).<br>
<br><br>
Pharmacokinetics:<br>
PSD-04 plasma concentrations during study days.<br>
<br><br>
Pharmacodynamics (primary):<br>
Echocardiography: Left ventricular diastolic function parameters and ejection fraction.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Subjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicty then subjects in the placebo arm.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
The patients are either randomised in the PCD-04 group or in the placebo group.
Publiek
Zernikedreef 10
F.J.F. Broeyer
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246431
fbroeyer@chdr.nl
Wetenschappelijk
Zernikedreef 10
F.J.F. Broeyer
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246431
fbroeyer@chdr.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Female;
2. Willing and able to give written informed consent;
3. Between 20 – 75 years of age;
4. Scheduled for the current clinical routine protocol for adjuvant chemotherapy for carcinoma of the breast consisting of doxorubicin / cyclophosphamide cycles.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients with indication of distant metastases of breast carcinoma;
2. Inability to obtain a good quality echocardiogram before study drug administration;
3. Patients who are unable to remain in supine condition for more than 1 hr;
4. Patients with (a history of) malignant disease other than carcinoma of the breast;
5. Patients with hepatic disorders evidenced by elevated transamines above 3 times the upper limit of normal;
6. Patients with a renal disorder requiring renal replacement therapy;
7. Patients with a life expectancy of less than 1 year for whatever clinical condition.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL199 |
| NTR-old | NTR236 |
| Ander register | : N/A |
| ISRCTN | ISRCTN56637853 |