|- candidate number||1413|
|- NTR Number||NTR236|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||A double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.|
|- Scientific Title||A double blind, placebo controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity.|
|- hypothesis||Subjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicty then subjects in the placebo arm.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- Inclusion criteria||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.
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-sep-2003|
|- planned closingdate||1-dec-2005|
|- Target number of participants||72|
|- Interventions||The patients are either randomised in the PCD-04 group or in the placebo group.|
|- Primary outcome||Assessment of safety: |
this include evaluation of general safety (Blood pressure, heartrate, monitoring of the patient during infusion, laboratory tests, urinalysis).
PSD-04 plasma concentrations during study days.
Echocardiography: Left ventricular diastolic function parameters and ejection fraction.
|- Secondary outcome||Pharmacodynamics (secondary):|
1. Biochemical markers for myocardial damage;
2. ECG parameters.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD. F.J.F. Broeyer|
|- CONTACT for SCIENTIFIC QUERIES||MD. J. Burggraaf|
|- Sponsor/Initiator ||LTT Bio-Pharma Co.|
(Source(s) of Monetary or Material Support)
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||7-sep-2005 - 17-sep-2008|