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New treatment option for Pancreatic Ductal Adenocarcinoma (PDAC)
Official title Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT06639724
What this study is testing
What is Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)?
Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel) is an investigational medicine, being studied as a potential treatment for pancreatic ductal adenocarcinoma (pdac).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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.
- History of Hepatitis B (defined as Hepatitis B surface antigen, HBsAg, reactive) or known active Hepatitis C virus (HCV) (defined as HCV RNA -...
- Active infection requiring systemic therapy.
See the full eligibility 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...
- 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.
- No evidence of metastatic disease.
- Lymphadenopathy (defined as nodes measuring \> 1cm in short axis) outside the surgical basin (i.e., para- aortic, peri-caval, celiac axis, or distant nodes) is considered M1 disease and makes the patient ineligible. If...
- For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease.
- Patient has adequate organ function as defined below:
- Absolute Neutrophil Count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L.
- Hemoglobin ≥ 9.0 g/dL
- aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SPGT) ≤ 2.5 X institutional upper limit of normal (ULN)
- Total Bilirubin ≤ 1.5 x institutional ULN or ≤3 × institutional ULN in Gilbert's Ds
- Serum creatinine ≤ 2 x institutional ULN
- For people able to become pregnant: use of highly effective contraception for at least 2 weeks prior to enrollment and agreement to use such a method during study participation.
- For people able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during study participation.
- 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.
- 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...
- 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.
- Major surgical procedure within 28 days prior to the first dose of study drug.
- Unable or unwilling to withhold or discontinue any prohibited or restricted medications/procedures for the specified windows during the study.
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.