Atorvastatin for Cancer

Overseen by Joaquina Baranda, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Joaquina Baranda

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a window-of-opportunity trial to determine if atorvastatin given for 1 to 4 weeks at a dose of 80 milligrams per day (mg/day) is sufficient to decrease the level of conformational mutant tumor protein 53 (p53) in malignant diseases (solid tumor and relapsed Acute Myeloid Leukemia (AML)).

Research Team

Joaquina Baranda, MD

Principal Investigator

The University of Kansas Cancer Center

Eligibility Criteria

This trial is for adults with various cancers, including solid tumors and blood cancers like relapsed AML, who are scheduled for surgery or between treatments. Participants must have TP53-positive or negative tumors, not be on recent cancer therapies, and have good organ function. Pregnant women can't join; neither can those with certain health conditions like active liver disease or a history of rhabdomyolysis.

Inclusion Criteria

A negative urine or serum pregnancy test within 7 days before Day 1 dose of study medication, if female participant is of childbearing potential.

I understand the study and can sign the consent myself.

My tumor is positive for the TP53 protein.

Exclusion Criteria

Hypersensitivity to atorvastatin or any component of the formulation

I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.

I have been diagnosed with squamous cell cancer of the oropharynx.

Treatment Details

Interventions

• Atorvastatin (HMG-CoA Reductase Inhibitor)

Trial Overview The trial tests if Atorvastatin (80 mg/day) taken for 1-4 weeks affects the levels of mutant p53 protein in malignant diseases. It's designed to see if this common cholesterol-lowering drug could help treat different types of cancer by targeting a specific protein involved in tumor growth.

Participant Groups

Group I: Atorvastatin Experimental Treatment 1 Intervention

Atorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial)

Atorvastatin is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia
• Prevention of cardiovascular disease

Approved in Japan as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in China as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Approved in Switzerland as Lipitor for:

• Hypercholesterolemia
• Mixed dyslipidemia
• Homozygous familial hypercholesterolemia

Who Is Running the Clinical Trial?

Joaquina Baranda

Lead Sponsor

Trials

1

Recruited

50+