18 Participants NeededMy employer runs this trial

Pitavastatin for Pancreatic Cancer

CF
Uo
Overseen ByUniversity of California Irvine Medical
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, Irvine
Must be taking: Gemcitabine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding Pitavastatin, a cholesterol-lowering medication, to standard cancer treatments can benefit individuals with unresectable pancreatic adenocarcinoma, a type of pancreatic cancer that cannot be surgically removed. The researchers aim to determine the safest dose of Pitavastatin that can be combined with the cancer drugs Gemcitabine and Nab-paclitaxel. Suitable candidates for this trial include those already receiving Gemcitabine for their pancreatic cancer without recent signs of progression. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I need to stop taking my current medications for the trial?

You will need to stop taking any statin medications at least 2 weeks before starting the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

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

Research has shown that pitavastatin, a drug commonly used to lower cholesterol, might also reduce the risk of pancreatic cancer. Some studies found that people taking pitavastatin had a lower chance of developing pancreatic cancer and chronic pancreatitis, which is inflammation of the pancreas. This suggests the drug might be safe and could help manage cancer risk.

The current trial is in an early stage, focusing mainly on finding a safe dose. However, previous studies provide some confidence about pitavastatin's safety in people. It's important to remember that more research is needed to confirm its safety and effectiveness in this trial.12345

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

Pitavastatin is unique in the treatment of pancreatic cancer because it repurposes a cholesterol-lowering drug to target cancer cells. Most treatments for pancreatic cancer involve chemotherapy, which attacks rapidly dividing cells, but pitavastatin works by potentially disrupting the metabolism of cancer cells, which could hinder their growth. Researchers are excited about this approach as it offers a novel mechanism of action, potentially leading to more effective and less toxic treatment options. Additionally, being an oral medication, it provides a more convenient administration compared to traditional intravenous chemotherapy.

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

Research has shown that pitavastatin might lower the risk of pancreatic cancer by reducing inflammation, which is linked to cancer. In studies with mice, pitavastatin slowed pancreatic tumor growth and extended the mice's lifespan. Another study found that people taking pitavastatin had a lower risk of developing pancreatic cancer. These findings suggest that pitavastatin could help treat pancreatic cancer by reducing inflammation. Participants in this trial will receive different dosages of pitavastatin to evaluate its effectiveness and safety in treating pancreatic cancer.23467

Who Is on the Research Team?

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Jennifer Valerin, MD, PhD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic pancreatic cancer who have already received 2–4 cycles of gemcitabine-based treatment without their cancer getting worse. Participants need to have adequate blood counts and organ function.

Inclusion Criteria

I have been diagnosed with advanced or metastatic pancreatic cancer.
* Hemoglobin ≥ 9.0 g/dL (transfusion is allowed)
I am on gemcitabine treatment and my cancer has not gotten worse after 2-4 cycles.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Gemcitabine with Nab-paclitaxel with or without Pitavastatin. Pitavastatin is dosed starting on cycle 1 day 1, once orally daily on days 1-28 every 4 weeks.

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and progression-free survival.

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Pitavastatin

Trial Overview

The study is testing if adding pitavastatin to standard chemotherapy (gemcitabine plus nab-paclitaxel) is safe and what dose should be used in future studies. All participants continue their current chemo, some get pitavastatin as well.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Pitavastatin, 4 mg, Dose Level +1Experimental Treatment1 Intervention
Group II: Pitavastatin, 2 mg, Dose Level 0Experimental Treatment1 Intervention
Group III: Pitavastatin, 1mg, Dose Level -1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

Citations

Study results indicate that pitavastatin inhibits interleukin ...

In mice, pitavastatin suppressed environmentally-induced inflammation in the skin and the pancreas and prevented the development of inflammation ...

Statin prevents cancer development in chronic ...

Interestingly, pitavastatin use correlates with a significantly reduced risk of chronic pancreatitis and pancreatic cancer in patients. Our ...

Pitavastatin Offers Therapeutic Potential in Cancers Arising ...

Epidemiological data indicate pitavastatin significantly lowers risks of chronic pancreatitis and pancreatic cancer. Statins are proposed as ...

Pitavastatin blocks chronic pancreatitis-associated ...

Treatment with pitavastatin, an inhibitor of IL-33 expression 39 , resulted in reduced risk of chronic hepatitis and liver cancer in mice and humans. Our ...

Statin therapy may prevent cancer by blocking ...

Study results indicate that pitavastatin inhibits interleukin-33 to suppress skin and pancreatic cancers. Date: June 1, 2024; Source ...

Statin prevents cancer development in chronic inflammation ...

Furthermore, the risk of pancreatic cancer was markedly decreased in the pitavastatin-treated group compared with the ezetimibe-treated control (OR 0.835; 95% ...

Cholesterol Lowering Statins May Block Cancer ...

... pitavastatin was linked with a significantly lower risk of chronic pancreatitis and pancreatic cancer. This finding is significant and could ...