A double-blind, placebo-controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity

ISRCTN ISRCTN56637853
DOI https://doi.org/10.1186/ISRCTN56637853
Secondary identifying numbers N/A
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr F.J.F. Broeyer
Scientific

Zernikedreef 10
Leiden
2333 CL
Netherlands

Phone +31 (0)71 5246431
Email fbroeyer@chdr.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleA double-blind, placebo-controlled study to assess the safety and efficacy of PCD-04 as a protective agent against anthracycline-induced cardiotoxicity
Study acronymPROTACMI
Study objectivesSubjects in the PCD-04 arm will show less anthracyclin-induced cardiotoxicity then subjects in the placebo arm.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionThe patients are either randomised in the PCD-04 group or in the placebo group.
Intervention typeOther
Primary outcome measure1. Assessment of safety: this include evaluation of general safety (blood pressure, heart rate, monitoring of the patient during infusion, laboratory tests, urinalysis)
2. Pharmacokinetics: PSD-04 plasma concentrations during study days
3. Pharmacodynamics (primary): echocardiography (ECG): left ventricular diastolic function parameters and ejection fraction
Secondary outcome measuresPharmacodynamics (secondary):
1. Biochemical markers for myocardial damage
2. ECG parameters
Overall study start date16/09/2003
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants72
Total final enrolment80
Key inclusion criteria1. 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
Key exclusion criteria1. 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 one hour
4. Patients with (a history of) malignant disease other than carcinoma of the breast
5. Patients with hepatic disorders evidenced by elevated transamines above three 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 one year for whatever clinical condition
Date of first enrolment16/09/2003
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Zernikedreef 10
Leiden
2333 CL
Netherlands

Sponsor information

LTT Bio-Pharma (Japan)
Industry

26th Floor, Atago Green Hills MORI Tower
2-5-1, Atago
Minato-ku
Tokyo
105-6201
Japan

Website http://www.ltt.co.jp/main_e.html
ROR logo "ROR" https://ror.org/016yy9j09

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2014 07/01/2021 Yes No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.