Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639724
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Perioperative Fostamatinib with Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Trial of Perioperative Fostamatinib with Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b trial evaluating the combination of Fostamatinib a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura ITP with the standard of care chemotherapy agents gemcitabine and nab-paclitaxel for the perioperative treatment of resectable non metastatic pancreatic ductal adenocarcinoma PDAC
Detailed Description:
Although immune checkpoint inhibition has transformed the treatment of some solid malignancies it has made minimal impact in pancreatic ductal adenocarcinoma PDAC which is characterized by a profoundly immunosuppressive microenvironment Recent published work by the study investigators demonstrated that inhibition of the Syk kinase - alone and in combination with gemcitabine - in preclinical models of PDAC animal tumor models and human tissues reprogrammed tumor associated macrophages resulting in enhanced anti-tumor immunity With this phase Ib study the investigators aim to expand the preclinical findings to patients with PDAC This study will evaluate perioperative fostamatinib in combination with standard of care chemotherapy with gemcitabine and nab-paclitaxel Study participants will receive 4 cycles preoperatively followed by pancreatic surgical resection and 2 cycles postoperatively Participants will be followed long term until death or until 2 years after enrollment whichever occurs first to evaluate safety and efficacy of perioperative fostamatinib in combination with gemcitabine and nab-paclitaxel
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