Fostamatinib + Chemotherapy for Pancreatic Cancer

Overseen By Shakeela Dad, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Disqualifiers: Prior PDAC treatment, Metastatic PDAC, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination treatment for individuals with a type of pancreatic cancer that hasn't spread. Researchers are testing Fostamatinib, a drug typically used for a blood condition, alongside standard chemotherapy drugs gemcitabine and nab-paclitaxel, to determine if this combination is more effective before surgery. It targets those with surgically removable pancreatic cancer who have not received prior treatment. Participants must undergo imaging to confirm their cancer is resectable, meaning it hasn't spread to critical blood vessels or other areas. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you must be able to withhold or discontinue any prohibited or restricted medications during the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the FDA has approved fostamatinib for treating chronic idiopathic thrombocytopenia purpura (ITP), confirming its safety for that condition. This study tests fostamatinib with two chemotherapy drugs, gemcitabine and nab-paclitaxel, for pancreatic cancer treatment.

Previous research on gemcitabine and nab-paclitaxel indicates that patients generally tolerated these drugs well, though some experienced side effects like fatigue and nausea. As a Phase 1 trial, the primary goal is to assess the safety of the drug combination and determine the optimal dose.

Participants might experience side effects, but the trial is closely monitored to address any issues. Prospective participants should discuss with the trial team to better understand the risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Fostamatinib is unique because it introduces a new mechanism of action by targeting the spleen tyrosine kinase (SYK), which plays a role in inflammation and cancer cell survival. Unlike the standard treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, which directly attack cancer cells, fostamatinib aims to disrupt the pathways that help cancer cells thrive. Researchers are excited about fostamatinib's potential to enhance the effectiveness of existing chemotherapy treatments, potentially leading to better outcomes for patients.

What evidence suggests that this treatment might be an effective treatment for pancreatic cancer?

Studies have shown that using gemcitabine and nab-paclitaxel together can help treat pancreatic cancer, with patients living for about six months on average. In this trial, participants will receive Fostamatinib in combination with gemcitabine and nab-paclitaxel. Fostamatinib, a drug already approved for a blood disorder, blocks a protein called Syk kinase, which aids cancer cell growth and survival. The researchers aim to enhance treatment effectiveness by adding Fostamatinib, potentially stopping cancer cells from growing and spreading. Early research suggests that this combination could improve treatment outcomes for pancreatic cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Andrew Lowy, MD

Principal Investigator

UCSD

Are You a Good Fit for This Trial?

This trial is for adults with non-metastatic, resectable pancreatic cancer who can consent to treatment. They must have good performance status (ECOG ≤ 1), no metastasis or major blood vessel involvement, and be considered a surgical candidate. Those with lymphadenopathy outside the surgical area are excluded unless biopsied negative.

Inclusion Criteria

My portal and splenic veins are not blocked.

I can understand and am willing to sign the consent form.

My cancer has not significantly spread to major blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive fostamatinib in combination with gemcitabine and nab-paclitaxel for 4 cycles

16 weeks

3 visits per 28-day cycle (in-person)

Surgical Resection

Participants undergo pancreatic surgical resection

1 week

Postoperative Treatment

Participants receive fostamatinib in combination with gemcitabine and nab-paclitaxel for 2 cycles

8 weeks

3 visits per 28-day cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Fostamatinib

Trial Overview

The study tests Fostamatinib combined with standard chemotherapy (gemcitabine and nab-paclitaxel) in patients undergoing surgery for pancreatic cancer. It's a Phase 1b trial to see how well this combination works as perioperative treatment.

How Is the Trial Designed?

Group I: Fostamatinib in combination with gemcitabine/nab-paclitaxel Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Rigel Pharmaceuticals

Industry Sponsor

Trials

37

Recruited

4,000+

Published Research Related to This Trial

In a study of 97 patients with advanced pancreatic adenocarcinoma treated with FOLFIRINOX, baseline splenomegaly was found to predict poorer progression-free survival (PFS) and overall survival (OS), indicating its potential as a biomarker for treatment response.

The predictive model, which included factors like performance status and liver metastasis, showed strong efficacy in predicting outcomes for patients treated with FOLFIRINOX, with an area under the curve (AUC) of 0.81, confirming the importance of splenic volume in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline splenic volume as a surrogate marker of FOLFIRINOX efficacy in advanced pancreatic carcinoma. Aarnink, A., Richard, C., Truntzer, C., et al.[2022]

Modified-FOLFIRINOX (mFOLFIRINOX) significantly improves safety and tolerability for Chinese patients with locally advanced pancreatic cancer (LAPC), with a response rate of 37.1% and common severe side effects including neutropenia and anemia.

Patients with LAPC who received neoadjuvant therapy with mFOLFIRINOX and subsequently underwent surgery had a median overall survival of 27.7 months, which is significantly better than the 8.9 months seen in patients who had upfront surgery without prior chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Modified-FOLFIRINOX-Regimen-Based Neoadjuvant Therapy with Outcomes of Locally Advanced Pancreatic Cancer in Chinese Population. Li, X., Guo, C., Li, Q., et al.[2023]

In a phase II trial involving 48 patients with gemcitabine-refractory unresectable pancreatic cancer, modified FOLFIRINOX demonstrated promising efficacy with an objective response rate of 18.8% and a disease control rate of 62.5%.

The treatment was associated with manageable safety concerns, primarily neutropenia (64.6% of patients), but most non-hematologic adverse events were mild, indicating that while effective, careful monitoring for hematologic toxicities is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer. Chung, MJ., Kang, H., Kim, HG., et al.[2020]

FOLFIRINOX, a combination chemotherapy regimen, has been shown to significantly improve overall survival and progression-free survival in patients with metastatic pancreatic cancer compared to the traditional treatment with gemcitabine, based on results from the PRODIGE 4/ACCORD 11 trial.

While FOLFIRINOX is associated with higher toxicity rates, including febrile neutropenia and diarrhea, its rapid adoption in clinical practice highlights its effectiveness, and further studies are needed to explore its benefits in other treatment settings like second-line therapy and adjuvant chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status on the place of FOLFIRINOX in metastatic pancreatic cancer and future directions. Lambert, A., Gavoille, C., Conroy, T.[2021]

FOLFIRINOX treatment in metastatic pancreatic carcinoma showed a median overall survival of 10 months, with similar efficacy whether used in first- or second-line therapy, indicating its effectiveness as a treatment option.

Patients with tumors located in the head of the pancreas had a poorer prognosis, with a median survival of only 8 months, compared to 14 months for those with tumors in the body or tail, highlighting the importance of tumor location in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influcence of localization of primary tumor on effectiveness of 5-fluorouracil/leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma: a retrospective study. Lorgis, V., Chauffert, B., Gentil, J., et al.[2022]

Citations

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This study will evaluate perioperative fostamatinib in combination with standard of care chemotherapy with gemcitabine and nab-paclitaxel.

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pmc.ncbi.nlm.nih.gov/articles/PMC12528555/

Emerging therapeutic advancements in pancreatic cancer

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Gemcitabine and nab-paclitaxel combined with afatinib in metastatic pancreatic cancer – Results of a phase 1b clinical trial. Author links open overlay panel

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clinicaltrials.ucsd.edu/pancreatic-cancer

UCSD Pancreatic Cancer Clinical Trials for 2025

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2- ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32957885/

Clinical Outcomes and Safety of Patients Treated with NAb ...

The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and ...