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HMG-CoA Reductase Inhibitor

Atorvastatin for Cancer

Phase 1

Waitlist Available

Led By Joaquina Baranda, MD

Research Sponsored by Joaquina Baranda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with tumor protein 53 (TP53) immunohistochemistry (IHC)-positive tumors

Participants whose screening IHC shows TP53-IHC-negative including wild type (WT) and null.

Must not have

Diagnosis of squamous cell cancer of the oropharynx

Participants who currently consume substantial quantities of alcohol (Male, more than 4 drinks a day, Female, more than 2 drinks a day)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if atorvastatin can decrease the level of mutant p53 in cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Atorvastatin may cause muscle pain or weakness (myopathy), liver problems, digestive issues, and increase the risk of diabetes. Rarely it might lead to severe muscle damage known as rhabdomyolysis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is positive for the TP53 protein.

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My cancer does not show TP53 protein in the screening.

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My cancer tissue samples are suitable for detailed genetic testing.

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I am fully active or can carry out light work.

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I have a confirmed cancer diagnosis and am eligible for surgery to remove it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not drink more than 4 (if male) or 2 (if female) alcoholic drinks a day.

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I have had rhabdomyolysis in the past.

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I have an ongoing liver condition.

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I am currently taking medication that can cause muscle weakness.

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My thyroid condition has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in conformational mutant tumor protein 53 (p53)

Secondary study objectives

Change in Ki-67 (protein)

Change in caspase-3

Side effects data

From 2014 Phase 3 trial • 58 Patients • NCT02084069

Postoperative bleeding

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AtorvastatinExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atorvastatin

1998

Completed Phase 4

~10900

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joaquina BarandaLead Sponsor

Joaquina Baranda, MD5.01 ReviewsPrincipal Investigator - The University of Kansas Cancer Center

University of Kansas Medical Center

2 Previous Clinical Trials

30 Total Patients Enrolled

5Patient Review

Dr. Baranda is an excellent oncologist who helped my husband and I understand his colorectal cancer, treatment options, and test results. She is compassionate and patient, and she really cares about her patients and their families. I would highly recommend her to anyone.