RecruitingPhase 1NCT06639724

Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer

A Phase 1b Trial of Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer

Sponsor

University of California, San Diego

Enrollment

36 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding fostamatinib — a drug that blocks a certain immune pathway — to the standard chemotherapy regimen (gemcitabine and nab-paclitaxel) before and after surgery improves outcomes for people with resectable pancreatic cancer. **You may be eligible if...** - You are 18 or older with resectable pancreatic ductal adenocarcinoma (cancer that can be surgically removed) - A surgical specialist has confirmed you are a candidate for surgery - Your cancer has been confirmed by imaging and has not spread to nearby major blood vessels or distant sites - Your blood counts, liver, and kidney function are within acceptable ranges - You are in good general health (ECOG ≤ 1) **You may NOT be eligible if...** - Your cancer is borderline resectable or unresectable (too close to major blood vessels or spread) - You have distant metastases - You are not healthy enough for chemotherapy or surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTFostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)

Fostamatinib is a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura but it has not been studied in PDAC. The investigators hypothesize that Syk inhibition reprograms macrophages to an immunostimulatory phenotype in the tumor microenvironment. Thus, Syk inhibition with fostamatinib in combination with chemotherapy could improve outcomes for patients with PDAC while having a favorable safety profile.