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Ovarian CancerEarly Phase 1NCT05080946

Using Aspirin to Improve Immunological Features of Ovarian Tumors

A Early Phase 1 study testing Aspirin 325mg in people with Ovarian Cancer and Fallopian Tube Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 4 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Aspirin 325mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
4 sitesUnited States
Study dates
2 Nov 2021to Dec 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants that are greater than or equal to 18 years of age
  • For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French
  • Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2/3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.
  • Treatment naïve for this cancer diagnosis
  • Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +/- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. [Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.]
  • Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
  • Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available.
  • If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement
  • Willing and able to swallow pills without difficulty
  • Un-transfused platelet count > 100,000 cells/μL
  • Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log/diary)
  • Absolute neutrophil count > 1.5 x 109 cells/L
  • Hemoglobin > 9.0 g/dL, may use transfusions and the value can be post-transfusion
  • Estimated creatinine clearance of > 30 mL/min, calculated using the formula Cockcroft-Gault [(140-age) x Mass (kg)/(72 x creatinine mg/dL)] x 0.85 for female
  • No severe hepatic impairment defined as AST or ALT elevation < 2.5 x institutional ULN, unless liver metastasis is present < 5 x ULN

Who cannot join

  • Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment
  • History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant [serious or significant] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions).
  • History of hypertensive crisis and/ or uncontrolled HTN, systolic blood pressure > 150 mmHg; diastolic blood pressure > 90mmHg. Participants must have blood pressure < 150/90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study.
  • Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated
  • History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study
  • Uncontrolled erosive esophagitis requiring 2 or more treatments
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  • Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer
  • Autoimmune disorder requiring systemic therapy
  • Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days.
  • Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy)
  • History of bariatric surgery
  • Currently pregnant at the Screening visit or planning on becoming pregnant during the study period
  • Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.
  • Metabolism CYP2C9, known G6PD deficient patients

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors

The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma

Being tested
Aspirin 325mg, Placebo
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin 325mgDrug

    Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.

  • PlaceboDrug

    Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.

Study groups in NCT05080946
Study groupRoleWhat they receive
Participants Randomized to AspirinExperimentalParticipants randomized to this arm will receive 325mg daily dose aspirin
Receives: Drug: Aspirin 325mg
Participants Randomized to PlaceboPlacebo comparatorParticipants randomized to this arm will receive a daily dose of a placebo (inactive substance)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery

    Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample.

    Measured: Up to 5 months

  2. Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery

    Change in intratumoral density of of M2 tumor-associated macrophages (CD163+ cells) will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample.

    Measured: Up to 5 Months

Secondary outcomes (6)

  1. Change in density of tumor COX1

    Change in density of tumor COX1 will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample.

    Measured: Up to 5 Months

  2. Change in density of tumor COX2

    Change in density of tumor COX2 will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample.

    Measured: Up to 5 Months

  3. Change in blood levels of IL-6

    Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

    Measured: Up to 84 days

  4. Change in blood levels of p-selectin

    Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

    Measured: Up to 84 days

  5. Change in blood levels of CA 125

    Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4

    Measured: Up to 84 days

  6. Change in tumor burden as defined by RECIST 1.1

    Change in tumor burden be assessed using Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1)

    Measured: Up to 5 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start2 Nov 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Study drug is expiring. Will reopen when new drug is received.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080946
Sponsor's protocol ID
MCC-20870
Other IDs
E01775.1a
Status last verified
Sep 2026
First submitted
5 Oct 2021
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Aspirin 325mg in people with Ovarian Cancer and Fallopian Tube Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 4 sites 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 16 inclusion and 14 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: paused, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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 intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery (time frame: Up to 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080946.

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 15 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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