Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT03003195
Status:
WITHDRAWN
Last Update Posted:
2024-09-03
First Post:
2016-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Funding
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 clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.
Detailed Description:
After signing Institutional Review Board (IRB) approved consent, subjects with metastatic cancer will be enrolled. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous injections of the vaccine on 4 separate occasions. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last approximately 12 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: