Can a statin tame a cancer protein? early trial seeks answers
NCT ID NCT03560882
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether the cholesterol drug atorvastatin can reduce levels of a faulty protein (p53) in people with various cancers, including solid tumors and leukemia. About 50 participants will take atorvastatin for 1 to 4 weeks before their planned surgery or treatment. The main goal is to see if the drug lowers the abnormal protein, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability of participant to understand this study, and participant to sign a written informed consent. Legally authorized representative is not allowed to sign consent for participant. * Participants with tumor protein 53 (TP53) immunohistochemistry (IHC)-positive tumors * Participants whose screening IHC shows TP53-IHC-negative including wild type (WT) and null. * Participants with histologic or cytologic confirmation of any malignant disease who are planning and eligible to undergo surgical resection. For participants with Solid Tumors Only * Participants with previously treated acute myeloid leukemia (AML) are eligible if they relapse and are in between two treatment regimens * No concurrent or recent (within 30 days) use of systemic therapy including chemotherapy, immunotherapy, hormonal therapy, cancer vaccine, or local therapy for the cancer. * Formalin-fixed paraffin-embedded (FFPE) tumor tissue deemed adequate for IHC analysis and next generation sequencing (NGS) are required. Bone marrow aspirate tissue samples from participants with AML are required. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate organ and marrow function * A negative urine or serum pregnancy test within 7 days before Day 1 dose of study medication, if female participant is of childbearing potential. * Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately. Exclusion Criteria: * Current or anticipated use of other investigational agents while participating in this study. * Pregnant or breast feeding. * Diagnosis of squamous cell cancer of the oropharynx * Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast), unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period * Prior use of statins in the past 30 days. * History of rhabdomyolysis * Active liver disease * Participants who currently consume substantial quantities of alcohol (Male, more than 4 drinks a day, Female, more than 2 drinks a day) * Concurrent use of drugs associated with myopathy * Hypersensitivity to atorvastatin or any component of the formulation * Untreated hypothyroidism * Inability to comply with study and follow-up procedures as judged by the Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Kansas Cancer Center - CRC
Fairway, Kansas, 66205, United States
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