Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148928
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2005-09-07
Brief Title:
Safety Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicenter Open-label Phase III Trial to Evaluate the Safety and Activity of CPC-P501 Protein Formulated With the Adjuvant AS15 as First-line Treatment in Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Patients with hormone-sensitive prostate cancer and rising PSA after primary tumor treatment will be treated with the P501-AS15 vaccine as out-patients The maximum dose will be 16 vaccinations given over a period of approximately one year Thereafter the patients long-term safety and PSA status will be followed over a period of approximately 11 months
Detailed Description:
This Phase III study will be conducted according to a multicenter open-label single-group design at approximately ten centers in Europe At least 21 HSPC patients with rising PSA after primary tumor treatment will be enrolled in this study All patients will be treated as out-patients and will receive the same treatment The maximum dose will be 16 vaccinations Follow-up The patients long-term safety and PSA status will be followed over a period of 48 weeks The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
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 |
|---|---|---|---|
| 104634 | None | None | None |