Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1NCT06639724
Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
A Phase 1 study testing Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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, 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.
- 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 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.
- For subjects able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during study participation.
Who cannot join
- 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 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego Moores Cancer Center
La Jolla, California, 92093
Project Manager, 858 822 5354, CancerCTO@health.ucsd.edu
Hitendra Patel, MD
About this study
Official title: A Phase 1b Trial of Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
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).
Read the detailed description
Although immune checkpoint inhibition has transformed the treatment of some solid malignancies, it has made minimal impact in pancreatic ductal adenocarcinoma (PDAC), which is characterized by a profoundly immunosuppressive microenvironment. Recent published work by the study investigators demonstrated that inhibition of the Syk kinase - alone and in combination with gemcitabine - in preclinical models of PDAC (animal tumor models and human tissues) reprogrammed tumor associated macrophages resulting in enhanced anti-tumor immunity. With this phase Ib study, the investigators aim to expand the preclinical findings to patients with PDAC. This study will evaluate perioperative fostamatinib in combination with standard of care chemotherapy with gemcitabine and nab-paclitaxel. Study participants will receive 4 cycles preoperatively, followed by pancreatic surgical resection and 2 cycles postoperatively. Participants will be followed long term until death or until 2 years after enrollment, whichever occurs first, to evaluate safety and efficacy of perioperative fostamatinib in combination with gemcitabine and nab-paclitaxel.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)
- Keywords
- PDAC, Pancreatic cancer, chemotherapy, Syk kinase inhibitor, Phase 1b, pancreatectomy, biomarkers, tumor microenvironment, non metastatic
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Fostamatinib in combination with gemcitabine/nab-paclitaxel | Experimental | 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. Receives: Combination Product: Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical delay
Number and percentage of participants who experience surgical delay, as measured by the proportion of enrolled participants for whom pancreatic resection cannot be performed within 6 weeks of the last pre-operative treatment cycle.
Measured: 6 weeks from the last pre-operative treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Rigel Pharmaceuticals
- Responsible party
- Principal investigator, Hitendra Patel, University of California, San Diego
- Investigators
- Andrew Lowy, MD, Study chair, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639724
- Sponsor's protocol ID
- 810834
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available
Publications
Rohila D, Park IH, Pham TV, Weitz J, Hurtado de Mendoza T, Madheswaran S, Ishfaq M, Beaman C, Tapia E, Sun S, Patel J, Tamayo P, Lowy AM, Joshi S. Syk Inhibition Reprograms Tumor-Associated Macrophages and Overcomes Gemcitabine-Induced Immunosuppression in Pancreatic Ductal Adenocarcinoma. Cancer Res. 2023 Aug 15;83(16):2675-2689. doi: 10.1158/0008-5472.CAN-22-3645.
PubMed 37306759
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06639724
- Acronym / sponsor ID
- 810834
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- PDAC, Pancreatic cancer, chemotherapy, Syk kinase inhibitor, Phase 1b, pancreatectomy, biomarkers, tumor microenvironment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Rigel Pharmaceuticals
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Although immune checkpoint inhibition has transformed the treatment of some solid malignancies, it has made minimal impact in pancreatic ductal adenocarcinoma (PDAC), which is characterized by a profoundly immunosuppressive microenvironment. Recent published work by the study investigators demonstrated that inhibition of the Syk kinase - alone and in combination with gemcitabine - in preclinical models of PDAC (animal tumor models and human tissues) reprogrammed tumor associated macrophages resulting in enhanced anti-tumor immunity. With this phase Ib study, the investigators aim to expand the preclinical findings to patients with PDAC. This study will evaluate perioperative fostamatinib in combination with standard of care chemotherapy with gemcitabine and nab-paclitaxel. Study participants will receive 4 cycles preoperatively, followed by pancreatic surgical resection and 2 cycles postoperatively. Participants will be followed long term until death or until 2 years after enrollment, whichever occurs first, to evaluate safety and efficacy of perioperative fostamatinib in combination with gemcitabine and nab-paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib in combination with gemcitabine/nab-paclitaxel | Experimental | Combination Product: Fostamatinib in combination with chemotherapy (gemcitabine and 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (11 listed)
- 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 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)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. | Combination product | Fostamatinib in combination with gemcitabine/nab-paclitaxel |
Primary outcome
Surgical delay
Time frame: 6 weeks from the last pre-operative treatment cycle
Number and percentage of participants who experience surgical delay, as measured by the proportion of enrolled participants for whom pancreatic resection cannot be performed within 6 weeks of the last pre-operative treatment cycle.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 37306759Rohila D, Park IH, Pham TV, Weitz J, Hurtado de Mendoza T, Madheswaran S, Ishfaq M, Beaman C, Tapia E, Sun S, Patel J, Tamayo P, Lowy AM, Joshi S. Syk Inhibition Reprograms Tumor-Associated Macrophages and Overcomes Gemcitabine-Induced Immunosuppression in Pancreatic Ductal Adenocarcinoma. Cancer Res. 2023 Aug 15;83(16):2675-2689. doi: 10.1158/0008-5472.CAN-22-3645.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Lowy, MD study chair
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hitendra Patel, MD (858-822-5354, CancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical delay (time frame: 6 weeks from the last pre-operative treatment cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.