Actively Recruiting
Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
Led by University of California, San Diego · Updated on 2026-04-07
36
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
R
Rigel Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign written informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Surgical consult confirming patient is a candidate for surgery within 28 days before enrollment
- Resectable primary pancreatic ductal adenocarcinoma confirmed by contrast-enhanced CT or MRI within 4 weeks before enrollment
- No involvement of celiac artery, common hepatic artery, or superior mesenteric artery
- No or less than 180-degree involvement between tumor and portal vein or superior mesenteric vein
- Patent portal vein and splenic vein confluence
- No evidence of metastatic disease
- No lymphadenopathy outside surgical basin unless negative biopsy confirmed
- For tumors in the body or tail of the pancreas, any splenic artery or vein involvement is considered resectable
- Adequate organ function including neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 9.0 g/dL
- AST and ALT less than or equal to 2.5 times institutional upper limit of normal
- Total bilirubin ≤ 1.5 times institutional upper limit of normal or ≤ 3 times in Gilbert's disease
- Serum creatinine ≤ 2 times institutional upper limit of normal
- For women able to become pregnant, use of highly effective contraception for at least 2 weeks before enrollment and during study
- For men able to cause pregnancy, use of condoms or other effective contraception during study
You will not qualify if you...
- Any prior treatment for pancreatic ductal adenocarcinoma
- Recurrent or metastatic pancreatic ductal adenocarcinoma
- Peripheral neuropathy greater than grade 2
- Received an investigational agent within 28 days before first study drug dose
- History of Hepatitis B or active Hepatitis C infection
- Active infection requiring systemic therapy
- Known psychiatric or substance abuse disorder interfering with trial cooperation
- History of solid organ or allogeneic bone marrow transplant
- Major surgery within 28 days before first study drug dose
- Unable or unwilling to stop prohibited medications or procedures during study
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
H
Hitendra Patel, MD
CONTACT
S
Shakeela Dad, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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