Can a common cholesterol pill help chemotherapy fight ovarian cancer?

NCT ID NCT07815704

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are studying whether adding daily atorvastatin to standard chemotherapy and surgery changes the immune cells inside advanced high grade serous tumors of the ovary, fallopian tube, or peritoneum. The trial enrolls 40 adults with Stage III or IV disease who cannot have upfront surgery. Participants receive atorvastatin alongside carboplatin and paclitaxel chemotherapy before and after interval debulking surgery. The main question is whether the drug reduces tumor-promoting macrophages, a type of immune cell that can help tumors grow.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atorvastatin, a common cholesterol-lowering statin pill
What this could lead to
If it works, adding a cheap, widely used statin could become a simple way to shift the tumor's immune environment and help standard treatment work better for advanced ovarian cancer.
What could go wrong
This is a small Phase 2 trial of 40 people, so any immune-cell changes may not translate into longer survival. Atorvastatin can cause muscle aches and rare liver or muscle problems, and it may not alter the tumor enough to matter.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

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

18 to 89 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be a patient with ovarian cancer aged 18-89 * Diagnosed via tissue biopsy not ascites * For persons of reproductive potential, use of highly effective method(s) of contraception. * Patients with primary Stage III/IV high-grade serous ovarian/fallopian tube/primary peritoneal cancer not amenable to upfront cytoreductive surgery. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2. * Absolute Neutrophil Count 1500 cells/mL * Platelet count \> 100,000 mL. * Hemoglobin 9.0 g/dL * Serum albumin ³ 2.5 g/dL. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * aspartate aminotransferase (AST )and alanine aminotransferase (ALT) ≤ 3.0 x ULN. * Serum creatinine ≤ 1.5x ULN Exclusion Criteria: * Inability to comply with study and follow-up procedures. * Significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within the past 3 months, unstable arrhythmia, or unstable angina. * Known clinically significant liver disease defined as AST and ALT \> 3.0 x ULN and/or total bilirubin ≥ 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease. * Participation in investigational clinical trial within last 30 days. * Medical history of untreated HIV infection. Patients with medical history of HIV infection are eligible provided they meet following criteria * Are stable on antiretroviral therapy for ≥4 weeks before randomization * Agree to adhere to antiretroviral therapy per World Health Organization (WHO) guidelines * Have no documented multi-drug resistance that would prevent effective antiretroviral therapy * Have a viral load of \<400 copies per mL at screening * Have CD4+ T cell count at ≥ 350 cells per μL * Have no history of acquired immunodeficiency syndrome (AIDS) -defining opportunistic infection ≤ 12 months before randomization. * Inability to provide informed consent. * Known central nervous system (CNS) malignancy or CNS metastases. * Patients with previous malignancy within the past 2 years from cycle 1, day 1, except those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast. * History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1). * Patients with prognosis for survival less than 6 months. * Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion. * Patients with duodenal stent or other gastrointestinal (GI) disorder/defect that would interfere with absorption of oral medication. o Includes patients unable to swallow orally administered medication and patients with GI disorders likely to interfere with absorption of the study medication * Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing. * Patients who are currently pregnant or lactating. * Prior or current statin use that would prohibit randomization into SOC arm. * Planned treatment with bevacizumab in the primary treatment setting. * Diagnosis based on ascites assessment only and not a tissue biopsy. * Patients deemed otherwise clinically unfit for clinical trial per investigators discretion

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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.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

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