CClinicalTrials.gg
Sign In
Active, not recruitingNCT03560882Updated May 6, 2026

A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies

A Phase 1 interventional study of Atorvastatin in Malignant Disease, Solid Tumor and Acute Myeloid Leukemia, sponsored by Joaquina Baranda. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Joaquina Baranda · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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)).

02

Conditions studied

  • Malignant Disease
  • Solid Tumor
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Cancer
  • Relapsed Hematologic Malignancy

Keywords

  • atorvastatin
  • p53
  • tumor resection
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 50 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

This is the only study on the registry with Joaquina Baranda as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Atorvastatin

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

    Drug: Atorvastatin

Interventions

  • DrugAtorvastatin

    Atorvastatin tablet, 80mg

06

What researchers measure

Primary outcomes

  1. Change in conformational mutant tumor protein 53 (p53)

    Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of conformation mutant p53.

    Time frame: baseline and up to 4 weeks

Secondary outcomes

  1. Change in Ki-67 (protein)

    Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of Ki-67 (also known as MKI67) in the conformation mutant p53 samples.

    Time frame: baseline and up to 4 weeks

  2. Change in caspase-3

    Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of caspase-3 in the conformation mutant p53 samples.

    Time frame: baseline and up to 4 weeks

07

Study locations

1 site
  • University of Kansas Cancer Center - CRC
    Fairway, Kansas 66205, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03560882
Lead sponsor
Joaquina Baranda
Responsible party
Joaquina Baranda (Associate Professor University of Kansas Cancer Center - Medical Oncology, University of Kansas Medical Center) — Sponsor-investigator
First posted
Jun 18, 2018
Start date
Jul 19, 2018
Primary completion
Oct 14, 2022
Completion
Aug 1, 2026 (estimated)
Last update
May 6, 2026

Study contacts

Joaquina Baranda, MD
principal investigator · The University of Kansas Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia, Myeloid, Acute→

Start the discussion