Malignant DiseasePhase 1NCT03560882
A Pilot Trial of Atorvastatin in Tumor Protein 53 (p53) -Mutant and p53 Wild-Type Malignancies
A Phase 1 study testing Atorvastatin in people with Malignant Disease and Solid Tumor, run by Joaquina Baranda at 1 site in United States.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Disease, Solid Tumor, Acute Myeloid Leukemia
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 1 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Cancer Center - CRC
Fairway, Kansas, 66205
About this study
Official title: A Pilot Trial of Atorvastatin in p53-Mutant and p53 Wild-Type Malignancies
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)).
- Conditions
- Malignant Disease, Solid Tumor, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Cancer, Relapsed Hematologic Malignancy
- Being tested
- Atorvastatin
- Keywords
- atorvastatin, p53, tumor resection
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin tablet, 80mg
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial) Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and up to 4 weeks
Secondary outcomes (2)
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.
Measured: baseline and up to 4 weeks
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.
Measured: baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start19 Jul 2018
- Primary completion14 Oct 2022
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joaquina Baranda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joaquina Baranda, University of Kansas Medical Center
- Investigators
- Joaquina Baranda, MD, Principal investigator, The University of Kansas Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560882
- Sponsor's protocol ID
- IIT-2018-p53Atorva
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2018
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Atorvastatin in p53-Mutant and p53 Wild-Type Malignancies
- ClinicalTrials.gov ID
- NCT03560882
- Acronym / sponsor ID
- IIT-2018-p53Atorva
- Conditions
- Malignant Disease, Solid Tumor, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Cancer, Relapsed Hematologic Malignancy
- Keywords
- atorvastatin, p53, tumor resection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Joaquina BarandaUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: AtorvastatinAtorvastatin 80 milligrams (mg) per day, orally for 1 - 4 weeks before surgery (surgery not part of clinical trial) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin tablet, 80mg | Drug | Atorvastatin |
Primary outcome
Change in conformational mutant tumor protein 53 (p53)
Time frame: baseline and up to 4 weeks
Measured by immunohistochemistry (IHC) staining. Reported as overall percent difference in the level of conformation mutant p53.
2 secondary outcomes
Change in Ki-67 (protein)
Time frame: baseline and up to 4 weeks
Change in caspase-3
Time frame: baseline and up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Malignant Disease
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquina Baranda, MD principal investigator
The University of Kansas Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin in people with Malignant Disease and Solid Tumor, run by Joaquina Baranda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in conformational mutant tumor protein 53 (p53) (time frame: baseline and up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.