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Caelyx PK.


- candidate number8786
- NTR NumberNTR2658
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2010
- Secondary IDs08-138 MEC Erasmus MC
- Public TitleCaelyx PK.
- Scientific TitleA pharmacokinetic study to assess age-related and intra-patient differences in the pharmacokinetics of intravenous pegylated liposomal doxorubicin in female cancer patients.
- ACRONYMCaelyx-PK
- hypothesisPharmacokinetics of caelyx may be altered in the elderly due to physiological changes.
- Healt Condition(s) or Problem(s) studiedCancer, Pharmacokinetics, Caelyx
- Inclusion criteria1. Woman;
2. Solid tumour;
3. Under treatment with calyx;
4. Age 18 years or older.
- Exclusion criteria1. Evidence of metastases in the central nervous system, unless previously treated and being asymptomatic/controlled for at least 3 months;
2. History of cardiac disease, with NYHA Class II or greater, or clinical evidence of congestive heart failure or myocardial infarction within less than six months;
3. Abuse of drugs, alcohol, pharmaceuticals, competing with adequate compliance in this study.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2008
- planned closingdate1-aug-2011
- Target number of participants34
- InterventionsPharmacokinetic sampling.
- Primary outcomeTo assess age-related differences in PEG DOXO area under the curve (AUC) in elderly as compared to younger female cancer patients.
- Secondary outcome1. To assess age-related differences in PEG DOXO clearance (Cl) and terminal half life (Tz) in elderly as compared to younger female cancer patients;
2. To assess intra-patient variation of the AUC, Cl and T in both cohorts;
3. To assess age-related differences in toxicities associated with PEG DOXO in elderly as compared to younger female cancer patients;
4. To relate the toxicities associated with PEG DOXO to the PK data in both cohorts.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.P. Hamberg
- CONTACT for SCIENTIFIC QUERIES A.P. Hamberg
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Medical Oncology
- PublicationsN/A
- Brief summaryPharmacokinetic evaluation of the impact of age on the pharmacokinetics of caelyx.
- Main changes (audit trail)
- RECORD16-dec-2010 - 3-jan-2011


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