This phase Ib trial tests the safety, side effects, and best dose of fostamatinib when given together with gemcitabine and nab-paclitaxel before and after surgery in patients with pancreatic ductal adenocarcinoma that can be removed by surgery (resectable). Fostamatinib is in a class of medications called kinase inhibitors. It may prevent the cancer's ability to grow and aid the body’s defense systems to fight the cancer cells while saving the non-cancerous, healthy, cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving fostamatinib, gemcitabine, and nab-paclitaxel before and after surgery may be safe, tolerable and/or effective in treating patients with resectable pancreatic ductal adenocarcinoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06639724.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer CenterStatus: Temporarily closed to accrual
Contact: Hitendra Patel
Phone: 858-822-3115
PRIMARY OBJECTIVE:
I. To evaluate the safety of perioperative fostamatinib in combination with gemcitabine/nab-paclitaxel in patients with resectable non metastatic pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVE:
I. To evaluate the efficacy of perioperative fostamatinib in combination with gemcitabine/nab-paclitaxel in patients with resectable non metastatic PDAC.
EXPLORATORY OBJECTIVE:
I. Evaluate the biological effects of fostamatinib in combination with gemcitabine/nab-paclitaxel on tumor tissue, including tumor cells and immune cells.
OUTLINE:
Patients receive fostamatinib orally (PO) twice daily (BID) on days 1-28 of each cycle, gemcitabine intravenously (IV) over 60 minutes and nab-paclitaxel IV over 30-40 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who show stable disease or response to treatment continue treatment for 2 more cycles (4 cycles total) prior to surgery. Patients then undergo a pancreatectomy 4-6 weeks after completion of the 4th treatment cycle. 4-6 weeks after surgery, patients continue to receive fostamatinib PO BID and gemcitabine/nab-paclitaxel IV on days 1, 8, and 15 for 2 more cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood collection and computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. Patients may also undergo biopsy during pancreatectomy on study.
After completion of study treatment, patients are followed up every 12 weeks until death or up to 2 years after enrollment, whichever occurs first.
Lead OrganizationUC San Diego Moores Cancer Center
Principal InvestigatorHitendra Patel