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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06639724
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel) — COMBINATION_PRODUCT
    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.

Study Details

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).

Key Dates

Start date
Dec 5, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fostamatinib in combination with gemcitabine/nab-paclitaxel
    Fostamatinib 100 mg will be taken by the study participants orally twice a day for 7 days prior to, and then during chemotherapy with gemcitabine/nab-paclitaxel. These 2 agents will be administered intravenously on days 1, 8, and 15 of each 28-day cycle.

Primary Outcome Measure

Surgical delay [ Time Frame: 6 weeks from the last pre-operative treatment cycle ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Diego Moores Cancer CenterLa JollaCalifornia92093
Project Manager
[email protected]
858 822 5354
Hitendra Patel, MD (PRINCIPAL_INVESTIGATOR)
Andrew Lowy, MD (SUB_INVESTIGATOR)

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By research site
University of California, San Diego Moores Cancer Center· La Jolla, CA

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