Early Phase 1 Ovarian Cancer Trial, Recruiting NCT05080946 Sponsor: H. Lee Moffitt Cancer Center and Research Institute Condition: Ovarian Cancer
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Early Phase 1 Ovarian Cancer Trial, Recruiting

NCT05080946
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People at U.S. trial sites who can read and understand English or Spanish, or at Canadian sites who can read and understand English or French
  • People who have been confirmed or are suspected to have a specific type of cancer affecting the ovaries, fallopian tubes, or the lining of the abdomen (peritoneum), of a moderate to high grade
  • People who have not yet received any treatment for this cancer diagnosis
  • People who are already planned to receive chemotherapy (a specific type using platinum and taxane drugs, with or without an additional targeted drug) for 3 to 5 cycles before surgery to remove the cancer
  • People who have measurable cancer visible on a CT scan taken within the past 12 weeks
  • People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities with minimal to no limitations)
  • People who are able to provide a tissue sample (biopsy) for testing, or who have a stored tissue sample from a previous procedure
  • People who take blood-thinning medication and whose doctor determines it is safe for them to temporarily stop during the study
  • People who are able to swallow pills without difficulty
  • People whose blood test results meet specific minimum levels for platelets (a type of blood cell that helps clotting), infection-fighting white blood cells, red blood cell levels (haemoglobin), and kidney function
  • People whose liver function blood test results are within an acceptable range
  • People who are willing and able to attend all required visits, procedures, and complete questionnaires and a pill diary throughout the study

Who may not be able to join:

  • People for whom their doctor determines there is a clear medical reason they should not take aspirin, or should not stop taking aspirin
  • People who have had a serious heart or blood vessel event in the past 12 months, such as a heart attack, stroke, heart surgery, significant abnormal heart rhythms, or heart failure
  • People with a history of very high blood pressure crises, or whose blood pressure currently measures above 150/90 mmHg when checked by a medical professional within 2 weeks before starting the study
  • People with a current or past history of stomach ulcers, severe liver failure, or serious kidney disease that would make taking aspirin unsafe
  • People who have had bleeding from the digestive system or urinary tract, or another bleeding or clotting disorder, within the past 6 months
  • People with uncontrolled severe inflammation of the oesophagus (food pipe) that has required two or more treatments
  • People who have been diagnosed with another cancer in the past 3 years, except for certain common skin cancers
  • People with an autoimmune condition that requires ongoing medical treatment
  • People who have used steroid medications for 3 weeks or more in the past year, or for any length of time in the past 30 days
  • People with a known allergy or sensitivity to aspirin or similar anti-inflammatory medications (NSAIDs)
  • People who have had weight-loss (bariatric) surgery
  • People who are currently pregnant or planning to become pregnant during the study
  • People who have difficulty swallowing medication, or have a digestive condition likely to affect how the study medication is absorbed
  • People who have a specific known genetic condition affecting how they process certain medications (G6PD deficiency), or a known issue with a specific liver enzyme involved in drug processing (CYP2C9) (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Jing-Yi Chern, MD, Moffitt Cancer Center

Phone: 813-745-2948

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
2 November 2021
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery; Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov