Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239239
Status:
COMPLETED
Last Update Posted:
2010-03-05
First Post:
2005-10-13
Brief Title:
Fractionated Dosing Study Study to Evaluate Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-label Single-arm Study to Evaluate the Pharmacokinetics Pharmacodynamics and Safety of Darbepoetin Alfa Administered Three Times Per Week for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-03
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:
The purpose of this study is to characterize the pharmacokineticspharmacodynamics PKPD of darbepoetin alfa administered at a subcutaneous SC dose of 045 mcgkg three times weekly TIW in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None