Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00736333
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2008-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).
Detailed Description:
Patients selected by investigator according to clinical routine
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: