Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer (NCT06639724) | Clinical Trial Compass
RecruitingPhase 1
Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
United States36 participantsStarted 2024-12-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient has the ability to understand and willingness to sign a written informed consent.
✓. Patient is ≥ 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
✓. Patient must have surgical consult to verify patient is a surgical candidate within 28 days prior to enrollment.
✓. Patient must have resectable primary PDAC based on contrast-enhanced CT or MRI of the chest, abdomen, and pelvis performed no more than 4 weeks before enrollment/baseline. Note that if CT or MRI was performed more than 4 weeks before this visit, imaging needs to be repeated to evaluate eligibility in the study. Resectable primary tumor is defined as:
✓. No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery).
✓. No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein.
✓. Patent portal vein/splenic vein confluence.
Exclusion criteria
✕. Any prior treatment for PDAC.
✕. Recurrent or metastatic PDAC.
✕. Peripheral neuropathy \> grade 2
✕. Received an investigational agent within 28 days prior to the first dose of study drug.
What they're measuring
1
Surgical delay
Timeframe: 6 weeks from the last pre-operative treatment cycle
✕. History of Hepatitis B (defined as Hepatitis B surface antigen, HBsAg, reactive) or known active Hepatitis C virus (HCV) (defined as HCV RNA - qualitative - is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. (Individuals who are hepatitis C antibody positive may be enrolled if negative viral load confirmed).
✕. Active infection requiring systemic therapy.
✕. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
✕. History of receiving a solid organ transplant or allogeneic bone marrow transplant.