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 |
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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
Scientific
Zernikedreef 10
Leiden
2333 CL
Netherlands
Phone | +31 (0)71 5246431 |
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fbroeyer@chdr.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Study acronym | PROTACMI |
Study objectives | Subjects 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) studied | Breast cancer |
Intervention | The patients are either randomised in the PCD-04 group or in the placebo group. |
Intervention type | Other |
Primary outcome measure | 1. 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 measures | Pharmacodynamics (secondary): 1. Biochemical markers for myocardial damage 2. ECG parameters |
Overall study start date | 16/09/2003 |
Completion date | 01/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 72 |
Total final enrolment | 80 |
Key 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 |
Key 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 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 enrolment | 16/09/2003 |
Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zernikedreef 10
Leiden
2333 CL
Netherlands
2333 CL
Netherlands
Sponsor information
LTT Bio-Pharma (Japan)
Industry
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 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/11/2014 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.