Caelyx PK.

Recruiting

• Conditions: pharmacokinetics; caelyx; cancer

• Registration Number: NL-OMON23804
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1. Woman;

2. Solid tumour;

Exclusion Criteria

1. 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;

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess age-related differences in PEG DOXO area under the curve (AUC) in elderly as compared to younger female cancer patients.

Secondary Outcome Measures

Name	Time	Method
1. To assess age-related differences in PEG DOXO clearance (Cl) and terminal half life (T½z) in elderly as compared to younger female cancer patients;<br /><br>2. To assess intra-patient variation of the AUC, Cl and T½ in both cohorts;<br /><br>3. To assess age-related differences in toxicities associated with PEG DOXO in elderly as compared to younger female cancer patients;<br /><br>4. To relate the toxicities associated with PEG DOXO to the PK data in both cohorts.