Ignite Creation Date:
2024-05-06 @ 2:49 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02132403
Status:
TERMINATED
Last Update Posted:
2015-05-01
First Post:
2014-05-05
Brief Title:
PM-01 IMPRIME PGG With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
PM-01 Phase 1b Study of PGG Beta Glucan Imprime PGG in Combination With Anti-MUC1 Antibody BTH1704 and Gemcitabine Gemzar for the Treatment of Advanced Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug Recall
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PM-01
Brief Summary:
This Phase Ib dose escalation study will evaluate BTH1704 a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1 and Imprime PGG a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells in combination with gemcitabine in patients with advanced PDAC The three intravenous drugs are taken in tandem 4 times in a 28-day cycle The MAD of BTH1704 BTH 3 dose levels in combination with gemcitabine Gem and Imprime PGG I will be determined using a standard 33 design Treatment continues until disease progression unacceptable toxicity physician discretion or patient refusal
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