Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272662
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2006-01-05
Brief Title:
Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
Sponsor:
Affymax
Organization:
Affymax
Study Overview
Official Title:
A Phase 2 Open-Label Multi-Center Dose Escalation Study of the Safety Pharmacodynamics and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-12
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 evaluate the safety pharmacodynamics PD and pharmacokinetics PK of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy
Detailed Description:
This was a Phase 2 open-label multi-center sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks Q3W by subcutaneous injection associated with a hemoglobin increase of 1 gdL in 50 of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-003354-10 | EUDRACT_NUMBER | None | None |