Ovarian CancerPhase 2NCT07303894
A Study of Isoquercetin in People With Ovarian Cancer
A Phase 2 study testing Isoquercetin in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Epithelial Ovarian Cancer, Serous Ovarian Tumor
- What is being tested?
- Isoquercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Jan 2026to Jan 2032
- Phase
- Phase 2
- 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
- Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line chemotherapy (day 1 of isoquercetin should align with day 1 of cycle 1 or 2 of chemotherapy) for neoadjuvant, adjuvant, or advanced settings.
- Minimum age 18 years
- Life expectancy of greater than 6 months.
- ECOG performance status <2
- Participants must have preserved organ and marrow function as defined below:
- Platelet count > 50,000/mcL
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- Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (ULN)
- Total bilirubin < 3 x ULN without liver metastases and <5 x ULN in presence of liver metastases.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 X ULN without liver metastases and <5 x ULN in the presence of liver metastases.
- Estimated creatinine clearance (CrCl >30 ml/min)
- The effects of isoquercetin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed anticoagulation)
- Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)
- History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
- Familial bleeding diathesis
- Known diagnosis of disseminated intravascular coagulation (DIC)
- Currently receiving anticoagulant therapy
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- Current daily use of aspirin, clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g ibuprofen > 800 mg daily or equivalent)
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Known intolerance of (iso)quercetin, niacin or ascorbic acid (including known G6PD deficiency).
- Participants with known brain metastases
- Pregnant women are excluded from this study because isoquercetin is a PDI inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with isoquercetin, breastfeeding should be discontinued if the mother is treated with isoquercetin.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Jeffrey A Zwicker, MD, 646-608-3723
- Not yet recruiting
Beth Israel Deaconess Medical Center (Data Collection Only)
Boston, Massachusetts, 02215
Robert Flaumenhaft, MD, PhD, 617-735-4005
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, 11725
Jeffrey Zwicker, MD, 646-608-3723
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Jeffrey Zwicker, MD, 646-608-3723
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Jeffrey Zwicker, MD, 646-608-3723
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Jeffrey Zwicker, MD, 646-608-3723
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Jeffrey Zwicker, MD, 646-608-3723
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Jeffrey Zwicker, MD, 646-608-3723
About this study
Official title: Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer
The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.
- Being tested
- Isoquercetin, Placebo
- Keywords
- Ovarian Cancer, Epithelial Ovarian Cancer, Serous Ovarian Tumor, Isoquercetin, Memorial Sloan Kettering Cancer Center, 25-060
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoquercetinDrug
Cohort B and Cohort C will take isoquercetin
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Cohort B: Isoquercetin daily | Experimental | Not described Receives: Drug: Isoquercetin |
| Cohort C: Isoquercetin twice daily | Experimental | Not described Receives: Drug: Isoquercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline
The primary endpoint is the maximal inhibition of PDI-sensitive, platelet-dependent thrombin generation measured at either 3 or 6 weeks (relative to baseline).
Measured: up to 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start22 Jan 2026
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Zwicker, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303894
- Sponsor's protocol ID
- 25-060
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07303894
- Acronym / sponsor ID
- 25-060
- Keywords
- Ovarian Cancer, Epithelial Ovarian Cancer, Serous Ovarian Tumor, Isoquercetin, Memorial Sloan Kettering Cancer Center, 25-060
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 26 Dec 2025 (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.
The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Placebo | Placebo comparator | Other: Placebo |
| Cohort B: Isoquercetin daily | Experimental | Drug: Isoquercetin |
| Cohort C: Isoquercetin twice daily | Experimental | Drug: Isoquercetin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line chemotherapy (day 1 of isoquercetin should align with day 1 of cycle 1 or 2 of chemotherapy) for neoadjuvant, adjuvant, or advanced settings.
- Minimum age 18 years
- Life expectancy of greater than 6 months.
- ECOG performance status <2
- Participants must have preserved organ and marrow function as defined below:
Key exclusion criteria (11 listed)
- Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed anticoagulation)
- Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)
- History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
- Familial bleeding diathesis
- Known diagnosis of disseminated intravascular coagulation (DIC)
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 |
|---|---|---|
| IsoquercetinCohort B and Cohort C will take isoquercetin | Drug | Cohort B: Isoquercetin daily, Cohort C: Isoquercetin twice daily |
| PlaceboPlacebo | Other | Cohort A: Placebo |
Primary outcome
Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline
Time frame: up to 6 weeks from baseline
The primary endpoint is the maximal inhibition of PDI-sensitive, platelet-dependent thrombin generation measured at either 3 or 6 weeks (relative to baseline).
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 15 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Jeffrey Zwicker, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isoquercetin in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 8 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 12 inclusion and 11 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: looking for participants now, 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 8 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jeffrey Zwicker, MD (646-608-3723, zwickerj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline (time frame: up to 6 weeks from baseline). 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 15 Sep 2026.