RECRUITING

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

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)PDAC Pancreatic cancer chemotherapy Syk kinase inhibitor Phase 1b pancreatectomy biomarkers tumor microenvironment non metastatic

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1b Trial of Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer

Quick Facts

Study Start:2024-12-05

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06639724

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient has the ability to understand and willingness to sign a written informed consent. 2. Patient is ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 4. Patient must have surgical consult to verify patient is a surgical candidate within 28 days prior to enrollment. 5. 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: 1. No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery). 2. No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein. 3. Patent portal vein/splenic vein confluence. 4. No evidence of metastatic disease. 5. 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, however, such nodes are biopsied and are negative, then enrollment can be considered after review with the study principal investigator (PI) and/or co-investigator. 6. For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease. 6. Patient has adequate organ function as defined below: 1. Absolute Neutrophil Count ≥ 1.5 x 10\^9/L 2. Platelet count ≥ 100 x 10\^9/L. 3. Hemoglobin ≥ 9.0 g/dL 4. aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SPGT) ≤ 2.5 X institutional upper limit of normal (ULN) 5. Total Bilirubin ≤ 1.5 x institutional ULN or ≤3 × institutional ULN in Gilbert's Ds 6. Serum creatinine ≤ 2 x institutional ULN 7. For subjects 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. 8. For subjects able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during study participation.	1. Any prior treatment for PDAC. 2. Recurrent or metastatic PDAC. 3. Peripheral neuropathy \> grade 2 4. Received an investigational agent within 28 days prior to the first dose of study drug. 5. 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). 6. Active infection requiring systemic therapy. 7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 8. History of receiving a solid organ transplant or allogeneic bone marrow transplant. 9. Major surgical procedure within 28 days prior to the first dose of study drug. 10. Unable or unwilling to withhold or discontinue any prohibited or restricted medications/procedures for the specified windows during the study. 11. Pregnancy or lactation.

Inclusion Criteria

Exclusion Criteria

1. Patient has the ability to understand and willingness to sign a written informed consent.
2. Patient is ≥ 18 years of age.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Patient must have surgical consult to verify patient is a surgical candidate within 28 days prior to enrollment.
5. 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:
1. No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery).
2. No involvement, or \< 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein.
3. Patent portal vein/splenic vein confluence.
4. No evidence of metastatic disease.
5. 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, however, such nodes are biopsied and are negative, then enrollment can be considered after review with the study principal investigator (PI) and/or co-investigator.
6. For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease.
6. Patient has adequate organ function as defined below:
1. Absolute Neutrophil Count ≥ 1.5 x 10\^9/L
2. Platelet count ≥ 100 x 10\^9/L.
3. Hemoglobin ≥ 9.0 g/dL
4. aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SPGT) ≤ 2.5 X institutional upper limit of normal (ULN)
5. Total Bilirubin ≤ 1.5 x institutional ULN or ≤3 × institutional ULN in Gilbert's Ds
6. Serum creatinine ≤ 2 x institutional ULN
7. For subjects 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.
8. For subjects able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during study participation.

1. Any prior treatment for PDAC.
2. Recurrent or metastatic PDAC.
3. Peripheral neuropathy \> grade 2
4. Received an investigational agent within 28 days prior to the first dose of study drug.
5. 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).
6. Active infection requiring systemic therapy.
7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
8. History of receiving a solid organ transplant or allogeneic bone marrow transplant.
9. Major surgical procedure within 28 days prior to the first dose of study drug.
10. Unable or unwilling to withhold or discontinue any prohibited or restricted medications/procedures for the specified windows during the study.
11. Pregnancy or lactation.

Contacts and Locations

Study Contact

Hitendra Patel, MD

CONTACT

858-822-5354

CancerCTO@health.ucsd.edu

Shakeela Dad, PhD

CONTACT

858-822-5354

CancerCTO@health.ucsd.edu

Principal Investigator

Andrew Lowy, MD

STUDY_CHAIR

UCSD

Study Locations (Sites)

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Andrew Lowy, MD, STUDY_CHAIR, UCSD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-05

Study Completion Date2028-12

Study Record Updates

Study Start Date2024-12-05

Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

PDAC
Pancreatic cancer
chemotherapy
Syk kinase inhibitor
Phase 1b
pancreatectomy
biomarkers
tumor microenvironment
non metastatic

Additional Relevant MeSH Terms

Pancreatic Ductal Adenocarcinoma (PDAC)